Clinical trials: Afib
Atrial Fibrillation (AF), Stroke
Elite AF IDE Trial (Elite AF)
The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for…
- Trial name
- NCT07287436
- Testing
- WATCHMAN Elite LAAC Device
- Where
- 2 sites in United States
- Volunteers
- 400 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Omega™ Left Atrial Appendage (LAA) Occluder in Patients With Non-Valvular Atrial Fibrillation
Atrial fibrillation is associated with increased risk of stroke mostly because of clot formation in the left atrial appendage, a small alcove in the left atrium heart chamber.
- Trial name
- NCT03526471
- Testing
- Omega™ Left Atrial Appendage (LAA) Occluder
- Where
- 2 sites in Denmark, Thailand
- Volunteers
- 20 people
- Sponsor
- Vascular Innovations Co. Ltd.
Atrial Fibrillation
Japanese Pradaxa PMS, Long Term
The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab
- Trial name
- NCT03175198
- Testing
- Prazaxa® Capsules
- Where
- Japan
- Volunteers
- 5,660 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
RATE Registry - Registry of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) Episodes in the Cardiac Rhythm Management (CRM) Device Population
The purpose of this registry is to produce a prospective, outcome-oriented registry to document the prevalence of AT/AF in the CRM population by using the Advanced AT/AF Diagnostics in select SJM devices.
- Trial name
- RATE (NCT00837798)
- Testing
- CRM Device
- Where
- United States
- Volunteers
- 5,379 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Paroxysmal AF
CARTO® 3 System and Real Time Intracardiac Ultrasound
This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).
- Trial name
- IUAF (NCT01716663)
- Testing
- Catheter Ablation
- Where
- 26 sites in United States
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- Biosense Webster, Inc.
Stroke
AMPLATZER™ Amulet™ LAA Occluder Trial
The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial…
- Trial name
- Amulet IDE (NCT02879448)
- Testing
- Amulet Left Atrial Appendage Occluder, WATCHMAN Left Atrial Appendage Closure
- Where
- 115 sites in United States, Australia and 9 more
- Volunteers
- 1,878 people
- Sponsor
- Abbott Medical Devices
Any Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA Guidelines
Comparison of AAIsafeR and DDD Modes in Non-selected Patients
1 Purpose In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, single chamber atrial pacemakers…
- Trial name
- CAN-SAVE R (NCT01219621)
- Testing
- Symphony Dual Chamber Rate Responsive Device
- Where
- 10 sites in Canada
- Volunteers
- 450 people
- Sponsor
- Sorin Group Canada
Atrial Fibrillation
Topera C-FIRM Registry
This is a control registry to the E-FIRM registry to track conventional atrial fibrillation (AF) procedures in terms of clinical usage, handling, and the safety and effectiveness for the treatment of symptomatic atrial…
- Trial name
- NCT02407249
- Where
- 9 sites in Germany, Netherlands
- Volunteers
- 73 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
ABLATOR Brazil - Ablation Observational Study (Registry)
The purpose of this registry is to assess the performance and clinical effectiveness of a combination of St. Jude Medical (SJM)/Abbott mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).
- Trial name
- NCT03041233
- Testing
- Observation / Data Collection
- Where
- 12 sites in Brazil
- Volunteers
- 833 people
- Sponsor
- Abbott Medical Devices
Hemorrhage, Atrial Fibrillation, Postoperative
Prevention of Retained-Blood Outcomes With Active Clearance Technology
Postoperative bleeding is a common consequence after heart surgery which can significantly impact outcomes and costs . When bleeding occurs, reliable postoperative blood evacuation of the pleural, mediastinal and pericardial…
- Trial name
- NCT02145858
- Testing
- Blood drainage post cardiac surgery using PleuraFlow System
- Where
- 2 sites in United States
- Volunteers
- 891 people
- Sponsor
- ClearFlow, Inc.
Atrial Fibrillation
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients…
- Trial name
- OPTION (NCT03795298)
- Testing
- WATCHMAN FLX Implant, Market-approved OAC
- Where
- 114 sites in United States, Australia and 8 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.
- Trial name
- NCT00540787
- Testing
- Radiofrequency ablation, antiarrhythmic drugs, Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs, ThermoCool Radiofrequency Catheter
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 112 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation
A systematic literature review (SLR) will be conducted to understand the landscape of evidence on the relative safety and effectiveness/efficacy of dronedarone compared to sotalol in patients with AFib within interventional…
- Trial name
- NCT05279833
- Testing
- dronedarone, sotalol
- Where
- France
- Volunteers
- 87,810 people
- Sponsor
- Sanofi
Paroxysmal Atrial Fibrillation
Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation
This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation.
- Trial name
- MAGELLAN (NCT00741611)
- Testing
- HD Mesh Ablation System, Anti-arrhythmic drugs
- Where
- 13 sites in United States
- Volunteers
- 44 people
- Sponsor
- C. R. Bard
Atrial Fibrillation
Performance of QDOT Micro™ Catheter With nGEN Generator for Patients With AFIB.
This workflow study will further evaluate the acute performance and safety of the QDOT MICRO™ catheter in a clinical setting used in combination with nGEN Generator. Subjects will be followed for 7 days post procedure.
- Trial name
- NCT04545619
- Testing
- QDOT MICRO System
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Biosense Webster, Inc.
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
The purpose of this post market clinical investigation is to complete preliminary evaluation on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System and cardiac ablation will result in improved…
- Conditions
- Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Hypertension
- Trial name
- RDN+AF (NCT01907828)
- Testing
- Renal Artery Ablation, Cardiac Ablation
- Where
- 2 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact…
- Conditions
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cardiac Arrhythmia
- Trial name
- WAVE-MAP AF (NCT03882021)
- Testing
- A specific electrophysiology mapping protocol is applicable with the GRID catheter.
- Where
- 15 sites in Austria, Czechia and 7 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Sick Sinus Syndrome
Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
The purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial fibrillation.
- Trial name
- NCT00161538
- Testing
- Pacing leads to be implanted according randomization., Selection 9000 prevent AF an Diagnose AF
- Where
- 12 sites in Germany
- Volunteers
- 456 people
- Sponsor
- Medtronic BRC
Atrial Fibrillation
Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation
This post-market registry is designed to collect real world data on the use of the Globe PF System for the treatment of atrial fibrillation (AF).
- Trial name
- NCT07651852
- Testing
- Globe Pulsed Field System
- Where
- 2 sites in United States
- Volunteers
- 500 people
- Sponsor
- Kardium Inc.
Atrial Fibrillation, Stroke
The CONFORM Pivotal Trial
The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular…
- Trial name
- NCT05147792
- Testing
- CLAAS, WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder
- Where
- 94 sites in United States, Czechia and 4 more
- Volunteers
- 1,600 people
- Sponsor
- Conformal Medical, Inc