Clinical trials: Atrial Appendage
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
aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an…
- Trial name
- aMAZE (NCT02513797)
- Testing
- LARIAT + PVI, Pulmonary Vein Isolation
- Where
- 53 sites in United States
- Volunteers
- 600 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 (AF), Paroxysmal AF
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and…
- Conditions
- Atrial Fibrillation (AF), Paroxysmal AF, Persistent Atrial Fibrillation
- Trial name
- CLEAR (NCT07523620)
- Testing
- PVI Ablation, Left Atrial Appendage Occluder Implant
- Where
- 16 sites in Belgium, Czechia and 8 more
- Volunteers
- 240 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, Left Atrial Appendage
AMPLATZER Cardiac Plug (ACP) Registry-Long Term Follow-up Protocol
The objective of the AMPLATZER Cardiac Plug (ACP) Registry Long Term Follow-up study is to evaluate long term performance of the ACP in closure of the Left Atrial Appendage (LAA) in subjects with nonvalvular atrial fibrillation…
- Conditions
- Atrial Fibrillation, Left Atrial Appendage, Stroke
- Trial name
- ACPR (NCT01786486)
- Testing
- Amplatzer Cardiac Plug
- Where
- 15 sites in Czechia, Germany and 3 more
- Volunteers
- 204 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up Study
Multi-center, single-arm, prospective, post-market study of LAmbre™ LAA Closure System. To evaluate the immediate and long-term procedural success of Lifetech LAmbre™ occluders in patients.
- Trial name
- LISA (NCT03666780)
- Testing
- LAmbre Occluder
- Where
- 26 sites in China, Denmark and 7 more
- Volunteers
- 500 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Non-valvular Atrial Fibrillation
The CONFORMAL Early Feasibility Study
An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
- Trial name
- NCT03616028
- Testing
- left atrial appendage closure
- Where
- 11 sites in United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Conformal Medical, Inc
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
OPTION-EMEA Clinical Trial
The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with…
- Conditions
- Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Closure, Pulsed Field Ablation
- Trial name
- OPTION-EMEA (NCT07349121)
- Testing
- Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case, Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure
- Where
- 11 sites in Belgium, Croatia and 3 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
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
Left Atrial Appendage Aneurysm
K2 Medical KALPA X™ Mapping, Imaging and Navigation Device
This prospective, multi-center, non-randomized, single-blinded, open-label, single-arm, comparator study will enroll up to 100 eligible subjects from multiple sites undergoing LAAC procedure to evaluate the safety and performance…
- Trial name
- NCT05155943
- Testing
- KALPA X™
- Where
- 2 sites in Italy, Lithuania
- Volunteers
- 18 people
- Sponsor
- Cara Medical Ltd
Atrial Fibrillation (AF)
COCONUT Study Concomitant PVI and LAAC
In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and…
- Trial name
- COCONUT (NCT06861673)
- Testing
- Pulmonary vein isolation
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Asklepios proresearch
Non-valvular Atrial Fibrillation (AF), Left Atrial Appendage Closure
WATCHMAN FLX Pro European Registry
The WATCHMAN FLX Pro European registry is intended to gather real world clinical data for patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX™ Pro device.
- Trial name
- NCT07262255
- Testing
- Left atrial appendage closure
- Where
- 20 sites in Denmark, Germany and 4 more
- Volunteers
- 189 people
- Sponsor
- Boston Scientific Corporation
Atrial Appendage
Left Atrial Appendage Exclusion Study
Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the left atrial appendage in 100 patients.
- Trial name
- PLACE II (NCT01983605)
- Testing
- LARIAT Suture Delivery Device
- Where
- Poland
- Volunteers
- 96 people
- Sponsor
- AtriCure, Inc.
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
LAmbre™ Left Atrial Appendage Closure System Follow-Up Study
The purpose of this study is to conduct a continuous telephone follow-up study on subjects who had completed the one-year follow-up of the LAmbre™ left atrial appendage (LAA) system registration trial.
- Trial name
- NCT03693092
- Where
- 11 sites in China
- Volunteers
- 156 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Fibrillation
Feasibility Study of a Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation
The purpose of this study is to assess the safety and function of the Aegis Sierra Ligation System in accessing and closing off the left atrial appendage (LAA) using a minimally invasive epicardial access approach.
- Trial name
- LASSO-AF (NCT02583178)
- Testing
- Aegis Sierra Ligation System
- Where
- 7 sites in United States, Canada
- Volunteers
- 7 people
- Sponsor
- Aegis Medical Innovations
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