Serruys, Patrick W |
SURTAVI, NCT01586910: Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (). |
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| Active, not recruiting | N/A | 1746 | Europe, Canada, US | Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI) | Medtronic Cardiovascular | Severe Aortic Stenosis | 07/18 | 11/26 | | |
| Active, not recruiting | N/A | 121 | Europe | sirolimus drug coated balloon (SCB), paclitaxel releasing coronary balloon catheter | Concept Medicals BV | Coronary Artery Disease, DCB | 03/23 | 09/23 | | |
| Recruiting | N/A | 768 | Europe, RoW | Myval THV Series, Myval/Myval Inception THVs or any subsequent advanced version commercially available at the study site., Contemporary Valves (Sapien THV Series and Evolut THV Series), Sapien THV Series (Sapien 3/Sapien 3 Ultra THVs) and Evolut THV Series (Evolut R/Evolut PRO THVs ) or any subsequent advanced version commercially available at the study site. | Meril Life Sciences Pvt. Ltd. | Aortic Valve Stenosis | 03/24 | 12/33 | | |
CAGEFREEII, NCT04971356: 1-month DAPT Plus 5-month Ticagrelor Monotherapy Versus 12-month DAPT in Patients With Drug-coated Balloon |
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| Active, not recruiting | N/A | 1948 | RoW | Aspirin 100mg for 1-month (immediately after PCI), Ticagrelor 90mg for 6-month (immediately after PCI), Aspirin 100mg for 6-month (6-month post PCI), Aspirin 100mg for 12-month (immediately after PCI), Ticagrelor 90mg for 12-month (immediately after PCI) | Xijing Hospital | Antiplatelet Drug, Acute Coronary Syndrome, Angioplasty, Balloon | 03/24 | 12/26 | | |
NCT04561739: Paclitaxel-coated Balloon for Treatment of De-novo Non-complex Coronary Artery Lesions |
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| Active, not recruiting | N/A | 2272 | RoW | Paclitaxel coated balloon, Sirolimus eluting stents | Xijing Hospital | De Novo Stenosis, Coronary Artery Disease | 05/24 | 05/27 | | |
| Active, not recruiting | N/A | 307 | Europe, Japan | prasugrel Monotherapy, PCI with the SYNERGY® stent | Meditrix Corp, Fujita Health University, Boston Scientific Japan K.K., National University of Ireland, Galway, Ireland | Chronic Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome | 07/24 | 12/25 | | |
| Active, not recruiting | N/A | 1550 | Europe | SUPRAFLEX Cruz, SYNERGY | National University of Ireland, Galway, Ireland | Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arterial Occlusive Diseases, Vascular Diseases | 09/25 | 09/26 | | |
| Recruiting | N/A | 1386 | RoW | The WATCHMAN/WATCHMAN FLX device, Rivaroxaban + Clopidogre, Aspirin + Clopidogrel | Xijing Hospital | Atrial Fibrillation, Percutaneous Coronary Intervention | 09/25 | 09/27 | | |
Mieghem, Nicolas M Van |
NCT05491200 / 2021-005499-20: Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients |
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| Recruiting | 4 | 1608 | Europe, RoW | Prasugrel based short DAPT, Prasugrel based standard DAPT, OCT guided revascularization, Angio guided revascularization | Research Maatschap Cardiologen Rotterdam Zuid, Abbott Medical Devices | ST Elevated Myocardial Infarction, Dual Antiplatelet Therapy | 08/26 | 08/28 | | |
REDOX TAVI, NCT04171726: Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation |
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| Recruiting | 3 | 100 | Europe | Edoxaban | Erasmus Medical Center, Daiichi Sankyo, Inc. | Aortic Valve Stenosis | 06/23 | 09/23 | | |
SURTAVI, NCT01586910: Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (). |
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| Active, not recruiting | N/A | 1746 | Europe, Canada, US | Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI) | Medtronic Cardiovascular | Severe Aortic Stenosis | 07/18 | 11/26 | | |
NCT04147884: A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation |
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| Active, not recruiting | N/A | 4 | US, RoW | Millipede Transcatheter Annuloplasty Ring System (Millipede System) | Boston Scientific Corporation | Mitral Regurgitation Functional, Mitral Valve Disease, Cardiovascular Diseases | 12/21 | 11/26 | | |
| Recruiting | N/A | 250 | Europe | Coronary computed tomography angiography | Erasmus Medical Center | Coronary Artery Disease | 10/22 | 10/23 | | |
NCT03621501: Direct Complete Versus Staged Complete Revascularization in Patients Presenting With Acute Coronary Syndromes and Multivessel Disease |
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| Active, not recruiting | N/A | 1525 | Europe | Percutaneous coronary intervention, PCI | Erasmus Medical Center, Biotronik SE & Co. KG | Acute Coronary Syndrome | 10/22 | 10/26 | | |
PLUTO-II, NCT06204783: Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort II: Structural Heart Interventions |
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| Recruiting | N/A | 157 | Europe | Pressure volume (PV) loop measurement | Erasmus Medical Center | Heart Failure, Valvular Heart Disease, Aortic Stenosis, Mitral Insufficiency, Tricuspid Insufficiency | 05/24 | 05/25 | | |
| Active, not recruiting | N/A | 252 | Europe, Canada | Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis | Erasmus Medical Center, Boston Scientific Corporation | Aortic Valve Stenosis | 12/22 | 02/24 | | |
| Recruiting | N/A | 150 | Europe | Virtual Reality Immersion | Erasmus Medical Center | Aortic Stenosis, Severe, Anxiety | 12/22 | 05/23 | | |
NCT04799769: Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER V Study |
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| Recruiting | N/A | 90 | Europe | Percutaneous arterial closure device | Vivasure Medical Limited | Percutaneous Arteriotomy Closure | 01/23 | 03/23 | | |
PRECISE TAVI, NCT04473443: Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation |
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| Recruiting | N/A | 200 | Europe | FEops HEARTguideTM | Erasmus Medical Center, Feops | Aortic Valve Stenosis, Bicuspid Cardiac Valve | 02/23 | 06/23 | | |
NCT02661451: Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) |
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| Active, not recruiting | N/A | 178 | Europe, Canada, US | SAPIEN 3 THV, Optimal Heart Failure Therapy | Cardiovascular Research Foundation, New York, Cardialysis BV, Avania | Aortic Valve Stenosis | 02/23 | 02/25 | | |
| Recruiting | N/A | 150 | Europe | Coronary Physiology assessment | Erasmus Medical Center | Aortic Valve Stenosis, Mitral Regurgitation, Coronary Artery Disease, Fractional Flow Reserve | 03/23 | 03/23 | | |
PLUTO-I, NCT05909280: Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort I: Veno-arterial Extracorporeal Membrane Oxygenation |
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| Recruiting | N/A | 20 | Europe | Pressure-volume loop measurements | Erasmus Medical Center | Extracorporeal Membrane Oxygenation, Cardio/Pulm: Heart Failure | 11/24 | 12/24 | | |
NCT06181240: Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE) |
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| Recruiting | N/A | 400 | Europe | Intravascular lithotripsy | Bolt Medical | Coronary Artery Disease, Coronary Artery Calcification | 04/25 | 03/26 | | |
IABP ON-TIME, NCT06414187: Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and Non-Acute Coronary Syndrome Related Cardiogenic Shock |
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| Not yet recruiting | N/A | 400 | Europe | Intra-Aortic Balloon Pump | Erasmus Medical Center, Arrow International LCC (Subsidiary of Teleflex Inc.) | Cardiogenic Shock | 06/27 | 06/27 | | |
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 | | |
DTU-STEMI, NCT03947619: Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: the STEMI-DTU Trial |
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| Active, not recruiting | N/A | 527 | Europe, Canada, US | Impella CP® placement prior to reperfusion with Primary PCI | Abiomed Inc. | ST Elevation (STEMI) Myocardial Infarction of Anterior Wall | 09/24 | 10/30 | | |
PROVE, NCT05539573: ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis |
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| Active, not recruiting | N/A | 1043 | Europe | Planned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system. | University of Leipzig, National University of Ireland, Galway | Aortic Stenosis | 04/25 | 04/25 | | |
| Recruiting | N/A | 590 | Europe, RoW | Navitor Transcatheter Aortic Valve and FlexNav Delivery System | Abbott Medical Devices | Symptomatic Severe Aortic Stenosis | 06/25 | 02/36 | | |
NCT05069558: Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion |
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| Active, not recruiting | N/A | 450 | Europe, Canada, US | Investigational PFO Closure Device, Standard of Care PFO Closure Device | Occlutech International AB | Stroke, Patent Foramen Ovale, PFO | 11/25 | 10/26 | | |
| Recruiting | N/A | 650 | Europe, Canada, Japan, US, RoW | Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT) | Medtronic Cardiovascular | Moderate Aortic Valve Stenosis | 02/26 | 12/34 | | |
| Recruiting | N/A | 400 | Europe, Canada, US | Evolut R/PRO bioprosthesis, Edwards Sapien S3/Ultra bioprosthesis | Erasmus Medical Center | Valve Heart Disease | 05/26 | 05/26 | | |
APOLLO-EU, NCT05496998: Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - Trial |
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| Recruiting | N/A | 400 | Europe | Medtronic Intrepid™ TMVR TF System | Medtronic Cardiovascular | Mitral Regurgitation | 08/29 | 12/38 | | |
| Active, not recruiting | N/A | 52 | Europe, US | | Catharina Ziekenhuis Eindhoven | Aortic Valve Stenosis | 10/24 | 10/28 | | |
| Not yet recruiting | N/A | 456 | Europe | Impella 5.5, Inotropes | Amsterdam UMC, location VUmc, Abiomed Inc. | Cardiogenic Shock | 10/27 | 07/28 | | |
TRACE-NL, NCT05628779: Evaluating Edge-to-edge Transcatheter Tricuspid Valve Repair in Patients With Severe Symptomatic Tricuspid Regurgitation |
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| Enrolling by invitation | N/A | 150 | Europe | TriClip TTVr system (Abbott Vascular), PASCAL TTVr system (Edwards Lifesciences) | St. Antonius Hospital, ZonMw: The Netherlands Organisation for Health Research and Development | Tricuspid Valve Regurgitation, Nonrheumatic, Cardiac Catheterization, Heart Failure, Right Sided, Valve Regurgitation, Tricuspid | 11/27 | 11/27 | | |
ATLAS TAVI, NCT04914481: Anatomic Stenosis Severity as a Prognostic Marker in Patients With Low-Flow Low-Gradient Aortic Stenosis Undergoing TAVI |
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| Recruiting | N/A | 1500 | Europe, Canada, RoW | | Universitätsklinikum Hamburg-Eppendorf, Institut universitaire de cardiologie et de pneumologie de Québec | Low-Flow, Low-Gradient Aortic Stenosis | 12/22 | 12/25 | | |