Clinical trials: Left Atrial Appendage
Atrial Fibrillation
Lifetech LAmbre™ Left Atrial Appendage Closure System Post-Market Registry
Single-center, single-arm, prospective, post-market study of LAmbre™ LAA Closure System. To evaluate immediate and long term procedural success of Lifetech LAmbre™ occluders in patients.
- Trial name
- NCT04307927
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Fibrillation
AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB
Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left…
- Trial name
- RESTORE SR IIB (NCT00571779)
- Testing
- AtriCure Bipolar System
- Sponsor
- AtriCure, Inc.
Non-valvular Atrial Fibrillation, Embolic Stroke
Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
This clinical study is a prospective, multi-center, non-interventional study designed to investigate the safety and effectiveness of percutaneous LAA appendage closure by using LAmbre™ Left Atrial Appendage Occluder System.
- Trial name
- NCT04559243
- Testing
- Transthoracic Echocardiography
- Where
- 5 sites in China
- Volunteers
- 579 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Fibrillation
Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System
The objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism…
- Trial name
- NCT04807283
- Testing
- Left Atrial Appendage Closure
- Where
- 4 sites in Georgia, Paraguay
- Volunteers
- 29 people
- Sponsor
- Laminar, Inc.
Atrial Fibrillation
Sole-Therapy Treatment of Atrial Fibrillation
RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not…
- Trial name
- RESTORE SR II (NCT00566176)
- Testing
- Surgical Ablation using the AtriCure Bipolar System
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- AtriCure, Inc.
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
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
Safety and Effectiveness of Left Atrial Appendage Occlusion
This study is to evaluate acute and long-term safety and effectiveness of Left atrial appendage occlusion (LAA)with the AtriCure LAA Occlusion System.
- Trial name
- NCT00567515
- Testing
- AtriCure LAA Exclusion System
- Where
- Switzerland
- Volunteers
- 41 people
- Sponsor
- AtriCure, Inc.
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.
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
Atrial Fibrillation, Left Atrial Appendage Closure
Data Collection for Echocardiography-Based Software Assessment
This is a prospective, observational study collecting data from routine clinical care. The information gathered will be used to support the evaluation of a software-based tool.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Closure, Cardiovascular Diseases
- Trial name
- NCT07126600
- Testing
- No investigational intervention administered
- Where
- 6 sites in United States
- Volunteers
- 100 people
- Sponsor
- Anumana, 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
Atrial Fibrillation (AF), Mitral Valve (MV) Regurgitation
EPX-HTG for Structural Heart Procedures
To investigate and evaluate the benefits of adding EchoPixel Holographic Therapy Guidance to the current standard of care in Structural Heart (SH) procedures.
- Trial name
- EPX-HTG-2026 (NCT07705425)
- Testing
- Left Atrial Appendage Occlusion, Mitral Valve Transcatheter Edge to Edge Repair
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- EchoPixel, Inc.
Atrial Fibrillation
ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology
The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure Device in atrial fibrillation patients for which long term warfarin therapy is contraindicated.
- Trial name
- ASAP (NCT00851578)
- Testing
- WATCHMAN
- Where
- 4 sites in Czechia, Germany
- Volunteers
- 150 people
- Sponsor
- Boston Scientific Corporation
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 Appendage
CLAARITY is a Prospective, Observational, Single-arm, Multi-center, Post-market US Study Designed to Evaluate the Safety and Performance of the ECLIPTIS Left Atrial Appendage Exclusion System for Exclusion of the Left Atrial Appendage (LAA) During Concomitant Open-heart Cardiac Surgery.
CLAARITY is a prospective, observational, single-arm, multi-center, post-market US study designed to evaluate the safety and performance of the ECLIPTIS clip in a minimum of 168 participants.
- Trial name
- CLAARITY (NCT07742839)
- Testing
- Edwards ECLIPTIS Left Atrial Appendage Exclusion System
- Volunteers
- 168 people
- Sponsor
- Edwards Lifesciences
Atrial Fibrillation
Safety and Efficacy Study of LAmbre LAA Closure Device for Treating AF Patients Who Cannot Take Warfarin
The aim of this study is to assess the efficacy, safety and performance of LAmbre left atrial appendage closure system in patients with non-valvular atrial fibrillation who cannot be treated with Warfarin.
- Trial name
- NCT02029014
- Testing
- LAA closure system
- Where
- China
- Volunteers
- 154 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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.
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.