Clinical trials: Atrial Appendage
Non-valvular Atrial Fibrillation
WAVECREST Post Market Clinical Follow-Up (PMCF) Study
The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in…
- Trial name
- NCT03204695
- Testing
- Percutaneous LAA Closure, Anticoagulation or Clopidogrel
- Where
- Belgium
- Volunteers
- 27 people
- Sponsor
- Coherex Medical
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
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.
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
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
Post-Operative Atrial Fibrillation
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Patients without a documented history of Atrial Fibrillation (AF) and will undergo a valve or Coronary Artery Bypass Graft (CABG) procedure with direct visual access to the Left Atrial Appendage (LAA) will be eligible to…
- Trial name
- ATLAS (NCT02701062)
- Testing
- AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems, Anticoagulation Therapy
- Where
- 22 sites in United States
- Volunteers
- 562 people
- Sponsor
- AtriCure, Inc.
Stroke
Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation
The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial…
- Trial name
- ASAP-TOO (NCT02928497)
- Testing
- WATCHMAN LAAC Device Implant, Single Antiplatelet Therapy or No Therapy (Control)
- Where
- 92 sites in United States, Belgium and 7 more
- Volunteers
- 481 people
- Sponsor
- Boston Scientific Corporation
Non-valvular Atrial Fibrillation
Observe the Safety and Effectiveness of the WATCHMAN FLX™ for Subjects in Hong Kong
The primary objective of this study is to observe the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation to reduce the risk of stroke in…
- Trial name
- NCT04096963
- Testing
- The WATCHMAN FLX Delivery System
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- 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
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.
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 Septal Defect, Atrial Fibrillation
Feasibility Study on the VERAFEYE System
The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure.
- Conditions
- Atrial Septal Defect, Atrial Fibrillation, Atrial Arrhythmia, Left Atrial Appendage Closure
- Trial name
- LUMINIzE (NCT05931835)
- Testing
- VERAFEYE System
- Where
- Ireland
- Volunteers
- 18 people
- Sponsor
- LUMA Vision Ltd.
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.
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
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
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
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
Left Atrial Appendage Exclusion
CLIP-IT Post-Market Study
The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.
- Trial name
- NCT06203054
- Testing
- Penditure™ Left Atrial Appendage (LAA) Exclusion System
- Where
- 15 sites in United States
- Volunteers
- 198 people
- Sponsor
- Medtronic Cardiac Surgery
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