Natale, Andrea |
FADE-DRT, NCT04502017: Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion |
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| Recruiting | 4 | 360 | US | ASA plus Clopidogrel, Genetic-Tailored AntiThrombotic Strategy, Half-Dose of novel OAC | Texas Cardiac Arrhythmia Research Foundation | Device-Related Thrombosis, Atrial Fibrillation, Left Atrial Appendage Occlusion | 12/22 | 12/23 | | |
| Recruiting | 4 | 360 | Europe, US | Catheter ablation, Ablation, Rate or Rhythm control antiarrhythmic drugs for atrial fibrillation, Antiarrhythmic Drug, Insertion of CardioMems Hemodynamic monitor, IPM, Empiric heart failure drug therapy, HFDrug | Electrophysiology Research Foundation | Atrial Fibrillation, Heart Failure, Diastolic Heart Failure | 12/24 | 06/25 | | |
CHANGE AFIB, NCT05130268: Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation |
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| Completed | 4 | 339 | US | Dronedarone, Multaq | American Heart Association, Duke Clinical Research Institute, Sanofi | Atrial Fibrillation | 01/24 | 06/24 | | |
RAAFT-3, NCT04037397: First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment |
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| Completed | 3 | 25 | US | Anti Arrhythmics, Pulmonary Vein Isolation performed by Radio Frequency Catheter Ablation | University of Pennsylvania, Biosense Webster, Inc., Texas Cardiac Arrhythmia Research Foundation | Atrial Fibrillation | 10/24 | 10/24 | | |
| Recruiting | N/A | 888 | US | | Texas Cardiac Arrhythmia Research Foundation | Atrial Fibrillation, Mild Cognitive Impairment, Dementia | 06/20 | 12/22 | | |
| Recruiting | N/A | 50 | US | radiofrequency catheter ablation, RFCA | Texas Cardiac Arrhythmia Research Foundation | Atrial Fibrillation, Obesity | 08/20 | 12/22 | | |
TREASURE, NCT03503253: Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures |
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| Recruiting | N/A | 120 | US | Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System, Azur Peripheral Coil System | Texas Cardiac Arrhythmia Research Foundation | Left Atrial Appendage Incomplete Closure | 05/21 | 05/22 | | |
GenCov, NCT04506229: Genetic Mechanisms Underlying SARS-CoV-2 Infection and the Impact of COVID-19 on Cognitive Function |
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| Recruiting | N/A | 60 | US | Whole exome sequencing, Cognitive function | Texas Cardiac Arrhythmia Research Foundation | Covid19 | 08/21 | 09/21 | | |
| Recruiting | N/A | 200 | Europe, US | ILR, PMK, ICD | Texas Cardiac Arrhythmia Research Foundation | COVID-19, Atrial Fibrillation New Onset | 12/21 | 12/23 | | |
PLEA, NCT04216667: Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation |
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| Terminated | N/A | 124 | Europe, US, RoW | Catheter ablation | Montefiore Medical Center, Biosense Webster, Inc. | Atrial Fibrillation | 06/23 | 06/23 | | |
| Completed | N/A | 153 | Canada, US | Transseptal Aortic Approach Catheter Ablation Procedure, Retrograde Aortic Approach Catheter Ablation Procedure | University of California, San Francisco | Neurocognitive Dysfunction | 11/23 | 11/23 | | |
AVANT GUARD, NCT06096337: Pulsed Field Ablation (PFA) Vs Anti-Arrhythmic Drug (AAD) Therapy As a First Line Treatment for Persistent Atrial Fibrillation |
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| Recruiting | N/A | 520 | Europe, Canada, US, RoW | FARAPULSE™ Pulsed Field Ablation (PFA) System, Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone | Boston Scientific Corporation | Persistent Atrial Fibrillation | 12/25 | 12/27 | | |
| Recruiting | N/A | 206 | Canada, US | cryoablation procedure | Adagio Medical | Sustained VT | 12/25 | 03/26 | | |
COFFEE-AF, NCT05464940: Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction |
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| Not yet recruiting | N/A | 100 | US | Intravenous caffeine, Masked Placebo | Kansas City Heart Rhythm Research Foundation, Kansas City Heart Rhythm Institute, Overland Park, KS, Texas Cardiac Arrhythmia Institute, Austin, TX, USA, Loma Linda University, Loma Linda, California, USA | Atrial Fibrillation | 06/25 | 09/25 | | |
| Active, not recruiting | N/A | 152 | Europe, US | ensoETM. Esophageal cooling during AF ablation, Esophageal temperature monitoring probe | Advanced Cooling Therapy, Inc., d/b/a Attune Medical, University of Pennsylvania, Berry Consultants, Texas Cardiac Arrhythmia Research Foundation, Beth Israel Deaconess Medical Center, Kansas City Cardiac Arrhythmia Research LLC | AF - Atrial Fibrillation, Complication, Atrio-Esophageal Fistula | 05/26 | 05/26 | | |
| Active, not recruiting | N/A | 435 | Europe, Canada, US, RoW | Pulsed Field Ablation | Abbott Medical Devices | Atrial Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation | 01/26 | 01/26 | | |
DISRUPT-AF, NCT06335082: A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF |
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| Enrolling by invitation | N/A | 2000 | US | Pulsed Field Ablation | Heart Rhythm Clinical and Research Solutions, LLC, Boston Scientific Corporation | Atrial Fibrillation | 11/26 | 01/27 | | |
| Active, not recruiting | N/A | 153 | US | Standard Cryoballoon Pulmonary Vein Isolation (PVI), Arctic Front Advance Cardiac Cryoablation System, Cryoballoon PVI + Posterior Wall Isolation | Dignity Health Medical Foundation, Mercy General Hospital and Dignity Health Medical Foundation, Beth Israel Deaconess Medical Center, UC Health Medical Center, MedStar Georgetown University Hospital and Medical Center, Tampa Cardiac Specialists, Bethesda North Hospital, Brigham and Women's Hospital, Texas Cardiac Arrhythmia Institute At St. Davids Medical Center, St. Luke's Hospital and Health Network, Pennsylvania, Sarasota Memorial Health Care System, Nebraska Methodist Hospital-Methodist Physicians Clinic | Persistent Atrial Fibrillation | 04/24 | 12/24 | | |
ULTRA-HFIB, NCT04182620: Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation |
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| Active, not recruiting | N/A | 160 | US | renal denervation, Catheter ablation | Vivek Reddy | Atrial Fibrillation | 03/25 | 03/25 | | |
PLATINUM, NCT05510167: Post-ablation Alcohol Impacts Arrhythmia Recurrence, Quality of Life and Cognition in AF |
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| Not yet recruiting | N/A | 130 | NA | Study arm | Texas Cardiac Arrhythmia Research Foundation | Atrial Fibrillation | 08/24 | 08/25 | | |
SAFFICIENT, NCT06488820: Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers |
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| Recruiting | N/A | 2276 | US | Catheter ablation using pulsed-field ablation (PFA) system | Texas Cardiac Arrhythmia Research Foundation | Atrial Fibrillation | 08/26 | 08/27 | | |
| Active, not recruiting | N/A | 949 | US | WATCHMAN FLX Pro LAAC Device, Left Atrial Appendage Closure | Boston Scientific Corporation | Atrial Fibrillation, Bleeding, Stroke | 07/24 | 08/25 | | |
| Recruiting | N/A | 1857 | US | WATCHMAN FLX Pro LAAC Device, WATCHMAN FLX Pro Left Atrial Appendage Closure Device | Boston Scientific Corporation | Atrial Fibrillation, Stroke, Bleeding | 07/26 | 01/27 | | |
| Enrolling by invitation | N/A | 583 | US | | Boston Scientific Corporation | Paroxysmal Atrial Fibrillation | 07/25 | 10/25 | | |
EFACT, NCT06699056: AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor |
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| Recruiting | N/A | 1500 | US | 15-minutes of sitting during COR ECG Acquistion | Peerbridge Health, Inc | Ventricular Ejection Fraction, LVF, LV Dysfunction, Atrial Enlargement, Conduction Defect, Heart Failure, Valvular Heart Disease, Ischemic Heart Disease, Cardiotoxicity, Myocardial Infarction, Dilated Cardiomyopathy, HFrEF - Heart Failure with Reduced Ejection Fraction, HFpEF - Heart Failure with Preserved Ejection Fraction, Syncope, Remodeling, Cardiac | 09/25 | 09/25 | | |
NCT06676072: A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects with PAF: |
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| Recruiting | N/A | 188 | Europe, US | PFA Ablation catheter | Abbott Medical Devices | Atrial Fibrillation (AF), Atrial Arrhythmia, Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation | 04/26 | 04/26 | | |
NCT05988411: ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation Vs Control in Redo Ablation Patients |
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| Recruiting | N/A | 250 | US | Renal Denervation, Catheter Ablation | Vivek Reddy | Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation | 12/27 | 12/27 | | |
NCT03643224: DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation |
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| Completed | N/A | 376 | Europe, Canada, US, RoW | Radiofrequency Ablation | Medtronic Cardiac Rhythm and Heart Failure | Persistent Atrial Fibrillation, Atrial Fibrillation | 10/24 | 10/24 | | |
ADVANTAGE AF, NCT05443594: A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation |
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| Active, not recruiting | N/A | 669 | Europe, Canada, US | Phase 1: FARAPULSE Ablation System, Phase 2: FARAPULSE Ablation System | Boston Scientific Corporation | Persistent Atrial Fibrillation | 03/25 | 03/25 | | |
| Recruiting | N/A | 142 | Europe, US | AtriCure ISOLATOR Synergy Surgical Ablation System | AtriCure, Inc. | Inappropriate Sinus Tachycardia | 06/26 | 06/27 | | |
IVTCC, NCT04520347: 2.0: a Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry |
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| Enrolling by invitation | N/A | 10000 | Europe, Canada, Japan, US, RoW | | University of California, Los Angeles | Ventricular Arrhythmia, Ventricular Tachycardia, Premature Ventricular Contraction (PVC), Cardiomyopathy | 12/26 | 11/27 | | |
| Recruiting | N/A | 500 | Europe, US | AtriCure Commercially Available Devices | AtriCure, Inc. | Inappropriate Sinus Tachycardia, Postural Tachycardia Syndrome | 01/27 | 01/27 | | |
| Recruiting | N/A | 4000 | Europe, Canada, US | WATCHMAN device | Hamilton Health Sciences Corporation, McMaster University, Population Health Research Institute, Boston Scientific Corporation | Atrial Fibrillation, Stroke, Ischemic, Systemic Embolism | 09/29 | 12/29 | | |
| Recruiting | N/A | 500 | US | Rapid antibody test | Texas Cardiac Arrhythmia Research Foundation | IgM and IgG in Blood | 03/22 | 03/22 | | |
| Not yet recruiting | N/A | 382 | US | Imaging | Kansas City Heart Rhythm Research Foundation, Kansas City Heart Rhythm Institute, Texas Cardiac Arrhythmia Research Foundation, Montefiore Medical Center, Loma Linda University International Heart Institute | Myocarditis, Ischemia, Chest Pain | 03/25 | 05/25 | | |
Reddy, Vivek Y |
PROSPECT, NCT06765356: Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias |
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| Not yet recruiting | 4 | 275 | US | Farapulse Catheter System, Low-dose Colchicine | Vivek Reddy, Boston Scientific Corporation | Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Long-standing Persistent Atrial Fibrillation | 03/27 | 03/27 | | |
| Active, not recruiting | 3 | 514 | US | Argatroban, Eptifibatide, Placebo | Washington University School of Medicine, National Institute of Neurological Disorders and Stroke (NINDS) | Acute Ischemic Stroke | 12/23 | 04/25 | | |
| Terminated | 3 | 248 | US, RoW | Coherex WaveCrest® Left Atrial Appendage Occlusion System, Watchman® LAA Closure Device | Coherex Medical, Biosense Webster, Inc. | Stroke | 12/23 | 12/23 | | |
NCT05026866: A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3) |
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| Active, not recruiting | 3 | 2196 | Japan, US | Donanemab, LY3002813, Placebo | Eli Lilly and Company | Alzheimer Disease | 11/27 | 11/27 | | |
| Recruiting | 2 | 300 | US | TS23 | Translational Sciences, Inc., University of Cincinnati, National Institute of Neurological Disorders and Stroke (NINDS), Medical University of South Carolina, University of Arizona | Ischemic Stroke | 07/27 | 12/27 | | |
| Terminated | N/A | 109 | US | MFAM | Vivek Reddy, Biosense Webster, Inc. | Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation | 10/22 | 10/22 | | |
NCT04358029: Cardiac Arrhythmias In Patients With Coronavirus Disease (COVID-19) |
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| Completed | N/A | 4000 | US | | Vivek Reddy | COVID 19 Cardiac, COVID 16 Arrhythmia, COVID 19 Death | 04/23 | 04/23 | | |
ADVENT, NCT04612244: The FARAPULSE PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation |
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| Completed | N/A | 706 | US | FARAPULSE Pulsed Field Ablation System, RadioFrequency and Cryoballoon Ablation | Farapulse, Inc. | Paroxysmal Atrial Fibrillation | 05/23 | 05/23 | | |
| Recruiting | N/A | 206 | Canada, US | cryoablation procedure | Adagio Medical | Sustained VT | 12/25 | 03/26 | | |
| Recruiting | N/A | 25 | US | Farawave PFA catheter | Vivek Reddy | Long-standing Persistent AF | 06/25 | 06/25 | | |
| Active, not recruiting | N/A | 435 | Europe, Canada, US, RoW | Pulsed Field Ablation | Abbott Medical Devices | Atrial Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation | 01/26 | 01/26 | | |
ULTRA-HFIB, NCT04182620: Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation |
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| Active, not recruiting | N/A | 160 | US | renal denervation, Catheter ablation | Vivek Reddy | Atrial Fibrillation | 03/25 | 03/25 | | |
| Recruiting | N/A | 300 | US | OPTIMIZER® Integra CCM-D System (Treatment Arm) | Impulse Dynamics | Heart Failure, Heart Failure with Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy, Non-ischemic Cardiomyopathy, Ischemic Cardiomyopathy, Sudden Cardiac Arrest, Arrhythmias, Cardiac, Ventricular Tachycardia, Ventricular Fibrillation | 06/25 | 12/25 | | |
CorCinch-HF, NCT04331769: Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF): the CORCINCH-HF Study |
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| Recruiting | N/A | 400 | Europe, US, RoW | AccuCinch Ventricular Restoration System, Guideline-Directed Medical Therapy | Ancora Heart, Inc. | Heart Failure with Reduced Ejection Fraction (HFrEF), Dilated Cardiomyopathy | 12/26 | 12/30 | | |
| Recruiting | N/A | 1857 | US | WATCHMAN FLX Pro LAAC Device, WATCHMAN FLX Pro Left Atrial Appendage Closure Device | Boston Scientific Corporation | Atrial Fibrillation, Stroke, Bleeding | 07/26 | 01/27 | | |
NEUROPULSE, NCT06748157: Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablation for Atrial Fibrillation |
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| Recruiting | N/A | 65 | US | CardiaCare RR2, Sham Device | Icahn School of Medicine at Mount Sinai, Ziv HealthCare Ltd. | Atrial Fibrillation | 04/25 | 04/25 | | |
| Enrolling by invitation | N/A | 583 | US | | Boston Scientific Corporation | Paroxysmal Atrial Fibrillation | 07/25 | 10/25 | | |
| Recruiting | N/A | 2650 | Europe, Canada, Japan, US, RoW | Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder), Amplatzer Amulet LAA Occluder, Non-Vitamin K Oral Antagonists, NOAC | Abbott Medical Devices | Atrial Fibrillation, Stroke, Bleeding | 08/27 | 08/30 | | |
NCT05988411: ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation Vs Control in Redo Ablation Patients |
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| Recruiting | N/A | 250 | US | Renal Denervation, Catheter Ablation | Vivek Reddy | Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation | 12/27 | 12/27 | | |
VIRTUE, NCT06056557: Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy |
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| Active, not recruiting | N/A | 141 | US | VARIPULSE™ catheter ablation | Vivek Reddy | Atrial Fibrillation, Paroxysmal or Persistent, Atrial Fibrillation and Flutter, Atrial Flutter Typical | 04/25 | 04/25 | | |
Sphere-9 VT, NCT06703489: Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia |
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| Not yet recruiting | N/A | 20 | NA | Sphere-9 Catheter with the Affera Mapping and Ablation System | Medtronic Cardiac Rhythm and Heart Failure | Ventricular Tachycardia (VT) | 06/25 | 01/26 | | |
FOCUS PFA, NCT06747013: Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation from a Point Ablation Catheter Short Title FOCUS-PFA |
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| Not yet recruiting | N/A | 30 | US | Point Ablation Catheter, Farapoint | Vivek Reddy, Boston Scientific Corporation | Focal Ventricular Arrhythmias, Premature Ventricular Contractions, Ventricular Tachycardias | 12/25 | 12/25 | | |
ADVANTAGE AF, NCT05443594: A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation |
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| Active, not recruiting | N/A | 669 | Europe, Canada, US | Phase 1: FARAPULSE Ablation System, Phase 2: FARAPULSE Ablation System | Boston Scientific Corporation | Persistent Atrial Fibrillation | 03/25 | 03/25 | | |
MODULAR ATP, NCT04798768: Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing |
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| Active, not recruiting | N/A | 297 | Europe, Canada, US, RoW | mCRM Therapy System, Communication of S-ICD to Leadless Cardiac Pacemaker (LCP) | Boston Scientific Corporation | Tachycardia, Ventricular, Arrhythmia, Ventricular | 05/24 | 12/30 | | |
| Active, not recruiting | N/A | 481 | Europe, Canada, US, RoW | WATCHMAN LAAC Device Implant, Single Antiplatelet Therapy or No Therapy (Control) | Boston Scientific Corporation | Stroke | 12/25 | 12/25 | | |
INTERCEPT, NCT05723926: Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation |
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| Not yet recruiting | N/A | 2000 | NA | Vine Filter, Vine Embolic Protection System | Javelin Medical, Population Health Research Institute | Atrial Fibrillation, Oral Anticoagulation, Stroke, Implant | 12/28 | 10/30 | | |
Tomassoni, Gery |
CHANGE AFIB, NCT05130268: Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation |
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| Completed | 4 | 339 | US | Dronedarone, Multaq | American Heart Association, Duke Clinical Research Institute, Sanofi | Atrial Fibrillation | 01/24 | 06/24 | | |
AVANT GUARD, NCT06096337: Pulsed Field Ablation (PFA) Vs Anti-Arrhythmic Drug (AAD) Therapy As a First Line Treatment for Persistent Atrial Fibrillation |
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| Recruiting | N/A | 520 | Europe, Canada, US, RoW | FARAPULSE™ Pulsed Field Ablation (PFA) System, Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone | Boston Scientific Corporation | Persistent Atrial Fibrillation | 12/25 | 12/27 | | |
| Active, not recruiting | N/A | 1686 | Europe, Canada, Japan, US, RoW | SyncAV programmed ON, Fixed AV delay | Abbott Medical Devices | Congestive Heart Failure | 06/25 | 12/25 | | |
| Recruiting | N/A | 300 | US | OPTIMIZER® Integra CCM-D System (Treatment Arm) | Impulse Dynamics | Heart Failure, Heart Failure with Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy, Non-ischemic Cardiomyopathy, Ischemic Cardiomyopathy, Sudden Cardiac Arrest, Arrhythmias, Cardiac, Ventricular Tachycardia, Ventricular Fibrillation | 06/25 | 12/25 | | |
| Recruiting | N/A | 2650 | Europe, Canada, Japan, US, RoW | Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder), Amplatzer Amulet LAA Occluder, Non-Vitamin K Oral Antagonists, NOAC | Abbott Medical Devices | Atrial Fibrillation, Stroke, Bleeding | 08/27 | 08/30 | | |
ADVANTAGE AF, NCT05443594: A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation |
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| Active, not recruiting | N/A | 669 | Europe, Canada, US | Phase 1: FARAPULSE Ablation System, Phase 2: FARAPULSE Ablation System | Boston Scientific Corporation | Persistent Atrial Fibrillation | 03/25 | 03/25 | | |
NCT03970343: Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy |
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| Recruiting | N/A | 620 | US | OPTIMIZER Smart System | Impulse Dynamics | Heart Failure | 03/26 | 03/26 | | |
LUX-Dx TRENDS, NCT04790344: Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System. |
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| Active, not recruiting | N/A | 525 | US | Investigational LUX-Dx ICM Implant | Boston Scientific Corporation | Heart Failure | 05/26 | 06/26 | | |
Baranchuk, Adrian |
| Active, not recruiting | N/A | 1686 | Europe, Canada, Japan, US, RoW | SyncAV programmed ON, Fixed AV delay | Abbott Medical Devices | Congestive Heart Failure | 06/25 | 12/25 | | |
Kessler, David |
| Active, not recruiting | N/A | 153 | US | Standard Cryoballoon Pulmonary Vein Isolation (PVI), Arctic Front Advance Cardiac Cryoablation System, Cryoballoon PVI + Posterior Wall Isolation | Dignity Health Medical Foundation, Mercy General Hospital and Dignity Health Medical Foundation, Beth Israel Deaconess Medical Center, UC Health Medical Center, MedStar Georgetown University Hospital and Medical Center, Tampa Cardiac Specialists, Bethesda North Hospital, Brigham and Women's Hospital, Texas Cardiac Arrhythmia Institute At St. Davids Medical Center, St. Luke's Hospital and Health Network, Pennsylvania, Sarasota Memorial Health Care System, Nebraska Methodist Hospital-Methodist Physicians Clinic | Persistent Atrial Fibrillation | 04/24 | 12/24 | | |
Sanchez, Javier |
NCT04088071: Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation |
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| Recruiting | N/A | 15000 | US | Catheter ablation | Heart Rhythm Clinical and Research Solutions, LLC, Biosense Webster, Inc. | Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation | 12/27 | 12/27 | | |
Horton, Rodney |
| Recruiting | N/A | 475 | Europe, Canada, US | Amulet™ 2 Left Atrial Appendage (LAA) Occluder | Abbott Medical Devices | Atrial Fibrillation (AF), Stoke | 07/26 | 07/28 | | |
| Recruiting | N/A | 2650 | Europe, Canada, Japan, US, RoW | Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder), Amplatzer Amulet LAA Occluder, Non-Vitamin K Oral Antagonists, NOAC | Abbott Medical Devices | Atrial Fibrillation, Stroke, Bleeding | 08/27 | 08/30 | | |
NCT03643224: DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation |
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| Completed | N/A | 376 | Europe, Canada, US, RoW | Radiofrequency Ablation | Medtronic Cardiac Rhythm and Heart Failure | Persistent Atrial Fibrillation, Atrial Fibrillation | 10/24 | 10/24 | | |
Tschopp, David |
| Recruiting | N/A | 142 | Europe, US | AtriCure ISOLATOR Synergy Surgical Ablation System | AtriCure, Inc. | Inappropriate Sinus Tachycardia | 06/26 | 06/27 | | |
| Recruiting | N/A | 400 | Europe, US | Arctic Front™ Cardiac Cryoablation Catheter System | Medtronic Cardiac Rhythm and Heart Failure | Persistent Atrial Fibrillation | 08/27 | 08/27 | | |
Cardinal, Deb |
REACT-AF, NCT05836987: The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation |
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| Recruiting | 3 | 5350 | US | AFSW Guided DOAC, Apple Watch, Continuous DOAC therapy, Oral Anticoagulation therapy | Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI) | Atrial Fibrillation | 07/29 | 07/29 | | |
| Completed | N/A | 117 | US | Patient Preference Survey | Abbott Medical Devices | Cardiac Rhythm Disorder, Bradycardia, Cardiac Pacemaker Artificial | 06/23 | 06/23 | | |
| Active, not recruiting | N/A | 152 | Europe, US | ensoETM. Esophageal cooling during AF ablation, Esophageal temperature monitoring probe | Advanced Cooling Therapy, Inc., d/b/a Attune Medical, University of Pennsylvania, Berry Consultants, Texas Cardiac Arrhythmia Research Foundation, Beth Israel Deaconess Medical Center, Kansas City Cardiac Arrhythmia Research LLC | AF - Atrial Fibrillation, Complication, Atrio-Esophageal Fistula | 05/26 | 05/26 | | |
DISRUPT-AF, NCT06335082: A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF |
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| Enrolling by invitation | N/A | 2000 | US | Pulsed Field Ablation | Heart Rhythm Clinical and Research Solutions, LLC, Boston Scientific Corporation | Atrial Fibrillation | 11/26 | 01/27 | | |
ULTRA-HFIB, NCT04182620: Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation |
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| Active, not recruiting | N/A | 160 | US | renal denervation, Catheter ablation | Vivek Reddy | Atrial Fibrillation | 03/25 | 03/25 | | |
| Recruiting | N/A | 300 | US | OPTIMIZER® Integra CCM-D System (Treatment Arm) | Impulse Dynamics | Heart Failure, Heart Failure with Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy, Non-ischemic Cardiomyopathy, Ischemic Cardiomyopathy, Sudden Cardiac Arrest, Arrhythmias, Cardiac, Ventricular Tachycardia, Ventricular Fibrillation | 06/25 | 12/25 | | |
SAFFICIENT, NCT06488820: Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers |
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| Recruiting | N/A | 2276 | US | Catheter ablation using pulsed-field ablation (PFA) system | Texas Cardiac Arrhythmia Research Foundation | Atrial Fibrillation | 08/26 | 08/27 | | |
| Recruiting | N/A | 1857 | US | WATCHMAN FLX Pro LAAC Device, WATCHMAN FLX Pro Left Atrial Appendage Closure Device | Boston Scientific Corporation | Atrial Fibrillation, Stroke, Bleeding | 07/26 | 01/27 | | |
| Recruiting | N/A | 475 | Europe, Canada, US | Amulet™ 2 Left Atrial Appendage (LAA) Occluder | Abbott Medical Devices | Atrial Fibrillation (AF), Stoke | 07/26 | 07/28 | | |
| Recruiting | N/A | 2650 | Europe, Canada, Japan, US, RoW | Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder), Amplatzer Amulet LAA Occluder, Non-Vitamin K Oral Antagonists, NOAC | Abbott Medical Devices | Atrial Fibrillation, Stroke, Bleeding | 08/27 | 08/30 | | |
NCT03643224: DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation |
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| Completed | N/A | 376 | Europe, Canada, US, RoW | Radiofrequency Ablation | Medtronic Cardiac Rhythm and Heart Failure | Persistent Atrial Fibrillation, Atrial Fibrillation | 10/24 | 10/24 | | |
| Recruiting | N/A | 1500 | US | Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System, CCM Group (CCM ON), OPTIMIZER™ Smart Mini System, Sham Group (CCM OFF) | Impulse Dynamics | Heart Failure, Heart Failure with Preserved Ejection Fraction, Heart Failure with Mid Range Ejection Fraction, Heart Failure with Moderately Reduced Ejection Fraction, Diastolic Heart Failure | 02/25 | 02/26 | | |
NCT03970343: Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy |
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| Recruiting | N/A | 620 | US | OPTIMIZER Smart System | Impulse Dynamics | Heart Failure | 03/26 | 03/26 | | |
| Recruiting | N/A | 142 | Europe, US | AtriCure ISOLATOR Synergy Surgical Ablation System | AtriCure, Inc. | Inappropriate Sinus Tachycardia | 06/26 | 06/27 | | |
Parfait, Vicky |
| Recruiting | N/A | 2650 | Europe, Canada, Japan, US, RoW | Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder), Amplatzer Amulet LAA Occluder, Non-Vitamin K Oral Antagonists, NOAC | Abbott Medical Devices | Atrial Fibrillation, Stroke, Bleeding | 08/27 | 08/30 | | |
Canby, Robert |
| Completed | N/A | 117 | US | Patient Preference Survey | Abbott Medical Devices | Cardiac Rhythm Disorder, Bradycardia, Cardiac Pacemaker Artificial | 06/23 | 06/23 | | |
| Recruiting | N/A | 300 | US | OPTIMIZER® Integra CCM-D System (Treatment Arm) | Impulse Dynamics | Heart Failure, Heart Failure with Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy, Non-ischemic Cardiomyopathy, Ischemic Cardiomyopathy, Sudden Cardiac Arrest, Arrhythmias, Cardiac, Ventricular Tachycardia, Ventricular Fibrillation | 06/25 | 12/25 | | |
| Active, not recruiting | N/A | 93 | US | BATwire Implant Kit | CVRx, Inc. | Heart Failure | 08/24 | 07/25 | | |
| Completed | N/A | 61 | US | Enabling Sensor Research Holter Mode feature | Medtronic Cardiac Rhythm and Heart Failure | Heart Failure | 06/24 | 06/24 | | |
NCT04496518: Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS) |
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| Active, not recruiting | N/A | 2200 | Europe, US | Intrinsic Antitachycardia Pacing (iATP) Therapy | Medtronic | Ventricular Tachycardia | 01/25 | 01/27 | | |
NCT04489225: Personalized Therapy Study - HFRS (TriageHF) Post Approval Study |
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| Active, not recruiting | N/A | 2200 | Europe, US | Observational | Medtronic | Heart Failure | 01/25 | 01/27 | | |
NCT03970343: Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy |
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| Recruiting | N/A | 620 | US | OPTIMIZER Smart System | Impulse Dynamics | Heart Failure | 03/26 | 03/26 | | |
ASQ, NCT04024943: Personalized Therapy Study - Attain Stability Quad Post-Approval Study |
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| Active, not recruiting | N/A | 1092 | Europe, US | Quadripolar LV Lead, Medtronic CRT-P, Medtronic CRT-D | Medtronic | Heart Failure | 01/27 | 04/27 | | |