Clinical trials: Atrial Appendage
Atrial Fibrillation, Stroke
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm.
- Trial name
- NCT00129545
- Testing
- WATCHMAN Left Atrial Appendage Closure Technology, Warfarin
- Where
- 62 sites in United States, Czechia and 1 more
- Volunteers
- 800 people
- Sponsor
- Boston Scientific Corporation
Left Atrial Appendage Absent
VCLIP Post-Market Study, Long-term Follow-up on LAA Exclusion Using AtriClip
Retrospective-prospective, multi-center, non-randomized, unblinded, post-market study to evaluate the long-term performance and safety of AtriClip® FLEX-V LAA and PRO•V LAA Exclusion devices for exclusion of the left atrial…
- Trial name
- VCLIP (NCT05101993)
- Testing
- AtriClip
- Where
- 11 sites in United States
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- AtriCure, 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
Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke
Registry on WATCHMAN Outcomes in Real-Life Utilization
The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism.
- Trial name
- EWOLUTION (NCT01972282)
- Testing
- WATCHMAN Left Atrial Appendage Closure
- Where
- 47 sites in Belgium, France and 11 more
- Volunteers
- 1,025 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Atrial Flutter
Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography
The presence of intracardiac thrombi and their propensity for systemic embolism is a major concern in patients with atrial fibrillation (AF) and atrial flutter (AFL) undergoing cardioversion and ablation procedures.
- Trial name
- ICE-TEE (NCT02213666)
- Testing
- Intracardiac Imaging
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Elad Anter
Left Atrial Appendage Occlusion
Study of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device
The purpose of this research is to to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN FLX™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol…
- Trial name
- NCT05136417
- Testing
- intra-procedural intracardiac echocardiography (ICE) probe
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
Cardiovascular Disease
A New Operation for the Treatment for Long-standing Atrial Fibrillation
Atrial fibrillation(AF) often occurs in patients with mitral valve disease. Both mitral replacement and mitral valve plasty are the effective methods to the mitral valve disease.
- Trial name
- ANOLAF (NCT03347695)
- Testing
- Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients), Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Fujian Medical University
Atrial Fibrillation, Stroke
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology.
- Trial name
- PREVAIL (NCT01182441)
- Testing
- WATCHMAN Device, Warfarin
- Where
- 41 sites in United States
- Volunteers
- 407 people
- Sponsor
- Boston Scientific Corporation
Non-valvular Atrial Fibrillation
The Conformal Prague Study
A prospective, single center, open-label, single arm, study to evaluate the safety and technical performance of the CLAAS system for closure of the left atrial appendage.
- Trial name
- NCT04193826
- Testing
- Left Atrial Appendage Closure
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- Conformal Medical, Inc
Atrial Fibrillation, Ischemic Stroke
AMPLATZER Cardiac Plug Clinical Trial
The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to…
- Conditions
- Atrial Fibrillation, Ischemic Stroke, Peripheral Thromboembolism
- Trial name
- NCT01118299
- Testing
- AMPLATZER Cardiac Plug
- Where
- 18 sites in United States
- Volunteers
- 97 people
- Sponsor
- Abbott Medical Devices
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
Left Atrial Appendage Exclusion
AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery
Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.
- Trial name
- EXCLUDE (NCT00779857)
- Testing
- AtriCure LAA Exclusion System
- Where
- 7 sites in United States
- Volunteers
- 70 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
Continued Access to PREVAIL (CAP2) - WATCHMAN Left Atrial Appendage (LAA) Closure Technology
To provide additional information about the safety and efficacy of the WATCHMAN LAA Closure Technology
- Trial name
- CAP2 (NCT01760291)
- Testing
- WATCHMAN LAA Closure Technology
- Where
- 3 sites in United States
- Volunteers
- 576 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Thromboembolism
AMPLATZER™ LAA Occluder Post Approval Study (PAS)
The aim of this multicenter, non-randomized observational post-approval is to compile real world outcome data on the use of an AMPLATZER LAA Occluder in subjects with non-valvular atrial fibrillation (NVAF).
- Conditions
- Atrial Fibrillation, Thromboembolism, Stroke
- Trial name
- NCT02964208
- Testing
- AMPLATZER™ LAA Occluder
- Where
- 22 sites in Argentina, Belgium and 5 more
- Volunteers
- 520 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage
The investigators intend to determine if using Optison echocardiography contrast increases sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal echocardiography studies as opposed to standard…
- Trial name
- DOLOP (NCT01721447)
- Testing
- Optison echocardiography contrast agent
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Utah
Stroke
WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2
The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.
- Trial name
- WAVECREST2 (NCT03302494)
- Testing
- Coherex WaveCrest® Left Atrial Appendage Occlusion System, Watchman® LAA Closure Device
- Where
- 25 sites in United States, Australia
- Volunteers
- 248 people
- Sponsor
- Coherex Medical
Atrial Fibrillation, Device Related Thrombus
Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study).
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers.
- Conditions
- Atrial Fibrillation, Device Related Thrombus, Left Atrial Appendage Thrombosis, Watchman LAA Closure Device
- Trial name
- DEA-LAA (NCT03539055)
- Testing
- Dabigatran Etexilate Oral Capsule
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Vanderbilt University Medical Center
Atrial Fibrillation Non-Rheumatic
A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W
The purpose of this study is to confirm the safety and effectiveness of the BSJ003W in Japanese patients with non-valvular atrial fibrillation at increased risk of thromboembolism in Japanese Clinical environment
- Trial name
- SALUTE (NCT03033134)
- Testing
- BSJ003W
- Where
- 10 sites in Japan
- Volunteers
- 54 people
- Sponsor
- Boston Scientific Japan K.K.
Atrial Fibrillation, Bleeding
HEAL-LAA Clinical Trial
The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.
- Conditions
- Atrial Fibrillation, Bleeding, Stroke
- Trial name
- HEAL-LAA (NCT05809596)
- Testing
- WATCHMAN FLX Pro LAAC Device
- Where
- 45 sites in United States
- Volunteers
- 949 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, AFib
Stroke Feasibility Study
This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage.
- Trial name
- NCT01997905
- Testing
- AtriClip LAA Exclusion Device
- Where
- 7 sites in United States
- Volunteers
- 13 people
- Sponsor
- AtriCure, Inc.