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 | | |
Mohanty, Mitra |
| 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 | | |
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 | 500 | US | Rapid antibody test | Texas Cardiac Arrhythmia Research Foundation | IgM and IgG in Blood | 03/22 | 03/22 | | |