Clinical trials: Left Atrial Appendage
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, Stroke
Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device
This study is a single-centre prospective post-market approval of the early experience with the Watchman FLX device for left atrial appendage closure in patients with atrial fibrillation at high risk of thromboembolic stroke and…
- Trial name
- REFLX (NCT03339193)
- Testing
- Left atrial appendage closure
- Where
- United Kingdom
- Sponsor
- Oxford University Hospitals NHS Trust
Atrial Fibrillation, Left Atrial Appendage Thrombosis
Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF
The primary objective is to demonstrate the safety and efficacy of the implantation of the LAmbre PlusTM device in patients with large or irregularly shaped appendages with non-valvular atrial fibrillation who are at increased…
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Thrombosis, CVA
- Trial name
- CORRAL-AF (NCT04684212)
- Testing
- LAmbre PlusTM Left Atrial Appendage Closure System, Market approved oral anticoagulation (OAC), such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)
- Where
- United States
- Sponsor
- Brian O'Neill MD
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
Low-dose NOAC Versus GDMT After LAAO
The increased risk of Atrial fibrillation (AF) regarding thromboembolic stroke is predominantly due to the formation and embolization of clots from within the left atrial appendage (LAA).
- Trial name
- RECORD-III (NCT05960721)
- Testing
- Rivaroxaban 15mg, Aspirin 100mg, Clopidogrel 75mg
- Where
- China
- Volunteers
- 4,220 people
- Sponsor
- Xijing Hospital
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
Cardiovascular Diseases
Left Atrial Appendage Occlusion Under Cone-beam Computed Tomography Fusion Image Guidance
Left atrial appendage occlusion is being widely recommended as a treatment strategy for patients with nonvalvular AF to prevent stroke, especially those who cannot tolerate long-term oral anticoagulation or have other reasons for…
- Trial name
- NCT05051280
- Testing
- cone-beam computed tomography fusion image
- Where
- China
- Volunteers
- 80 people
- Sponsor
- RenJi Hospital
Atrial Fibrillation
The Role of Multimodality Imaging in Left Atrial Appendage Closure
The aim of the present prospective, randomized single-centre study is to examine the success rate, safety, overall preoperative and operative burden and long-time outcome of percutaneous left atrial appendage closure procedures…
- Trial name
- MILAAC (NCT04800913)
- Testing
- Multimodal imaging, Standard imaging
- Where
- Hungary
- Volunteers
- 44 people
- Sponsor
- Hungarian Institute of Cardiology
Atrial Fibrillation (AF)
Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study
This is a single-arm, open label, clinical outcome study to research the durability (success) of receiving a pulsed field ablation (PFA) per standard of care for treatment of atrial fibrillation during a subsequent procedure for…
- Trial name
- PRECLUDE (NCT07620262)
- Testing
- Remapping Procedure
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Northwell Health
Thrombus
Accuracy of the 64 Slices Computed Tomography for the Diagnosis of Left Atrial Appendage Thrombus
Transoesophageal echocardiography (TEE) is considered as the gold standard method for detection of left atrial appendage (LAA) thrombus but is a semi-invasive investigation.
- Trial name
- THROMBI-SCAN (NCT01147796)
- Testing
- computed tomography
- Where
- France
- Volunteers
- 52 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Atrial Fibrillation
Left Atrial Appendage Closure in Combination With Catheter Ablation
This study is a prospective cohort study aimed at investigating the efficacy and safety of left atrial appendage closure in combination with catheter ablation in patients with atrial fibrillation.
- Trial name
- LAACablation (NCT03788941)
- Testing
- left atrial appendage closure and catheter ablation
- Where
- China
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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 (AF)
Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion
This randomized study was designed to compare two antithrombotic regimens (long-term half-dose apixaban vs long-term aspirin after 45-days of full-dose apixaban) after successful Watchman implantation.
- Trial name
- INTEGRAL (NCT07840365)
- Testing
- Half-Dose of novel OAC, Low-dose ASA
- Where
- United States
- Volunteers
- 234 people
- Sponsor
- Texas Cardiac Arrhythmia Research Foundation
Atrial Fibrillation
Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence of 1-2%. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5-6%.
- Trial name
- PRAGUE-17 (NCT02426944)
- Testing
- NOAC, Left atrial appendage closure
- Where
- Czechia
- Volunteers
- 400 people
- Sponsor
- Charles University, Czech Republic
Atrial Fibrillation
Changes of Left Atrial Function and Quality of Life After Transcatheter Closure of Left Atrial Appendage in Patients With Atrial Fibrillation
A total of 105 (AF) patients with atrial fibrillation are scheduled to undergo surgery and will be divided into three groups. Left atrial appendage occlusion ((LAAC)), radiofrequency ablation guided by three-dimensional mapping…
- Trial name
- NCT04376606
- Testing
- Left atrial appendage closure, Radiofrequency ablation, LAAC combined with radiofrequency ablation group
- Where
- China
- Volunteers
- 105 people
- Sponsor
- Ruiqin xie
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
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, PFA Ablation and LAAC Procedures
Left Atrial Appendage Closure With Versus Without Pulsed Field Ablation in Atrial Fibrillation Patients With Mild Symptoms and High Stroke Risk
This study is a prospective, multicenter, single-blinded, randomized controlled trial to investigate whether concomitant left atrial appendage closure (LAAC) and pulsed field ablation (PFA) is more effective than LAAC alone in…
- Trial name
- REVERSE-OPTION (NCT07453940)
- Testing
- LAAC plus PFA for persistent AF with high risk of stroke, LAAC for persistent AF with high risk of stroke
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Sir Run Run Shaw Hospital
Persistent Atrial Fibrillation
Effect of Empirical Left Atrial Appendage Isolation on Long-term Procedure Outcome in Patients With Persistent or Long-standing Persistent Atrial Fibrillation Undergoing Catheter Ablation
The purpose of this prospective randomized study is to assess whether empirical Left Atrial Appendage (LAA) isolation along with the standard approach of pulmonary vein isolation (PVI) and ablation of extra-pulmonary triggers is…
- Trial name
- BELIEF (NCT01362738)
- Testing
- RFCA of PV and extra-PV triggers, LAA isolation along with the conventional ablation strategy
- Where
- 2 sites in United States
- Volunteers
- 156 people
- Sponsor
- Texas Cardiac Arrhythmia Research Foundation