Clinical trials: Left Atrial Appendage
Atrial Fibrillation
Exploring the Efficacy of Once Daily Oral Rivaroxaban for Treatment of Thrombus in Left Atrial/Left Atrial Appendage in Subjects With Nonvalvular Atrial Fibrillation or Atrial Flutter
A study for subjects with atrial fibrillation (AF) or atrial flutter who are diagnosed with left atrial (LA) or left atrial appendage (LAA) thrombus. The study will assign subjects to rivaroxaban for treatment of thrombi.
- Trial name
- X-TRA (NCT01839357)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 31 sites in Bulgaria, France and 5 more
- Volunteers
- 60 people
- Sponsor
- Bayer
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
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
Cardiac Arrythmias, Left Atrial Appendage Closure
Agilis RF TSP Early Feasibility Study
This study is a prospective, acute, first-in-human, early feasibility study intended to assess the initial safety and performance of the Agilis™ Radiofrequency (RF) Transseptal (TSP) System in crossing the atrial septum for left…
- Trial name
- NCT07361445
- Testing
- Transseptal procedure with Agilis RF TSP System.
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Abbott Medical Devices
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
Applause Study I - Append System Early Feasibility Study
This early feasibility study is intended to evaluate the safety and feasibility of the Append System for eliminating the left atrial appendage (LAA) through a transcatheter procedure that invaginates and ligates the LAA tissue.
- Trial name
- Applause (NCT07278869)
- Testing
- Left Atrial Appendage Elimination: Append System
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Append Medical Ltd.
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 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, Left Atrial Appendage
AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational
The ACP device will be clinically evaluated through a prospective, open-label, nonrandomized, multi-center post market clinical study.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage, Stroke
- Trial name
- ACP LA (NCT01962051)
- Testing
- Amplatzer Cardiac Plug
- Sponsor
- Abbott Medical Devices
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 (AF), Bleeding
Concomitant PFA Bsaed PVI Plus LAAC
A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy…
- Conditions
- Atrial Fibrillation (AF), Bleeding, Stroke
- Trial name
- COCONUT_2 (NCT07450755)
- Testing
- Interventional LAA Closure, Pulmonary vein isolation
- Volunteers
- 150 people
- Sponsor
- Asklepios proresearch
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, Stroke
Feasibility and Safety Study of LAmbre Left Atrial Appendage Occluder
This study mainly evaluated the feasibility and safety of LAmbre Left Atrial Appendage Occluder which is to prevent ischemic stroke caused by atrial fibrillation(AF).
- Trial name
- NCT01920412
- Testing
- LAmbre Left Atrial Appendage(LAA) Occluder
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Fibrillation
Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage (LAA) in Patients With Atrial Fibrillation
This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA occluder indicated for percutaneous LAA closure in adult male or female patients with atrial fibrillation.
- Trial name
- OLAAC (NCT02105584)
- Testing
- Implantation of LAA closure device
- Where
- 7 sites in Germany, United Kingdom
- Volunteers
- 78 people
- Sponsor
- Occlutech International AB
Heart Diseases
Video-Assisted Left Atrial Appendage Exclusion Trial
Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique is safe and effective.
- Trial name
- VALET (NCT02226133)
- Testing
- LAAx, Inc. TigerPaw® System II
- Where
- 4 sites in United States
- Sponsor
- LAAx, Inc.
Atrial Fibrillation, Stroke
SIMPLAAFY Clinical Trial
The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- SIMPLAAFY (NCT06521463)
- Testing
- WATCHMAN FLX Pro LAAC Device
- Where
- 86 sites in United States
- Volunteers
- 1,857 people
- Sponsor
- Boston Scientific Corporation
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 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.
Left Atrial Appendage Occlusion
Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage
The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA
- Trial name
- NCT00841529
- Testing
- Medtronic LAA Occlusion Device
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Medtronic Cardiovascular
Persistent Atrial Fibrillation
WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm
WATCH-Rhythm is a prospective, randomized, multi-center, investigation to collect safety and effectiveness data on combining conventional AF ablation with LAA electric isolation and closure within a single procedure.
- Trial name
- WATCH-Rhythm (NCT03835338)
- Testing
- Pulmonary Vein Isolation, LAA Isolation, LAA Occlusion
- Sponsor
- Boston Scientific Corporation