Clinical trials: Left Atrial Appendage Closure, active
Intracerebral Hemorrhage, Atrial Fibrillation
Avoiding Anticoagulation After IntraCerebral Haemorrhage
Randomised controlled trials (RCTs) demonstrate a substantial benefit from oral anticoagulant drugs for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation (AF).
- Conditions
- Intracerebral Hemorrhage, Atrial Fibrillation, Microhaemorrhage
- Trial name
- A3ICH (NCT03243175)
- Testing
- Apixaban 5 MG, left atrial appendage closure
- Where
- 3 sites in France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Lille
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Oral Anticoagulation
Standalone Thoracoscopic Left Atrial Appendage Closure Versus Medical Therapy in Atrial Fibrillation
Surgical left atrial appendage closure (LAAC) has been associated with reduced rates of stroke in patients with atrial fibrillation (AF) who have undergone cardiac surgery.
- Conditions
- ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Oral Anticoagulation, Thoracotomy
- Trial name
- STELLA-AF (NCT07705282)
- Testing
- Video-assisted thoracoscopic closure of the left atrial appendage using a closure device and discontinuation of treatment if the patient is treated with OAC
- Where
- Sweden
- Volunteers
- 936 people
- Sponsor
- Region Skane
Aortic Stenosis
Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery
The primary purpose of the LAA-CLOSURE trial is to assess the efficacy and safety of surgical closure of LAA in patients undergoing aortic valve replacement.
- Trial name
- LAA-CLOSURE (NCT02321137)
- Testing
- Surgical closure of left atrial appendage, No closure of left atrial appendage
- Where
- 4 sites in Finland, Netherlands
- Volunteers
- 1,040 people
- Sponsor
- University of Turku
Atrial Fibrillation, Stroke
Prevention of Stroke by Left Atrial Appendage Closure in Atrial Fibrillation Patients After Intracerebral Hemorrhage
Intracerebral hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) poses a particular dilemma for thromboprophylaxis.
- Conditions
- Atrial Fibrillation, Stroke, Intracerebral Hemorrhage
- Trial name
- NCT02830152
- Testing
- LAAO, Medical Therapy
- Where
- 17 sites in Denmark, Finland and 2 more
- Volunteers
- 750 people
- Sponsor
- Karolinska Institutet
Atrial Fibrillation, Atrial Appendage
AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE
The APPENDAGE study is a phase 4 multicentre randomized opened clinical trial comparing 2 different antithrombotic strategies following left atrial appendage closure (LAAC) in patients with non valvular atrial fibrillation (AF).
- Conditions
- Atrial Fibrillation, Atrial Appendage, Anticoagulants, Stroke
- Trial name
- APPENDAGE (NCT04796714)
- Testing
- Double antiplatelet therapy, Aspirin, Brain MRI
- Where
- 2 sites in France
- Volunteers
- 60 people
- Sponsor
- University Hospital, Bordeaux
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
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
Surgical vs Percutaneous LAAO
Atrial fibrillation is the most common cardiac arrythmia globally. Its prevalence ranges between 2-4% worldwide. It is associated with significant morbidity and mortality.
- Trial name
- NCT05420701
- Testing
- TEE
- Volunteers
- 260 people
- Sponsor
- Chinese University of Hong Kong
Atrial Fibrillation
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that…
- Trial name
- NCT06099106
- Testing
- SEPIOLA System
- Where
- 5 sites in Georgia, Lithuania and 2 more
- Volunteers
- 15 people
- Sponsor
- Endomatic Ltd.
Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent
Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease
In the proposed event driven trial, LAA closure devices will be compared in a 1:1 randomization to best medical care in AF patients at high risk of stroke and bleeding with ESKD.
- Trial name
- LAA-KIDNEY (NCT05204212)
- Testing
- Left Atrial Appendage closure
- Where
- Germany
- Volunteers
- 430 people
- Sponsor
- Prof. Dr. med. Ingo Eitel
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, 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, Left Atrial Appendage Closure
Registry on Luma Vision's VERAFEYE System (ENLIgHT)
The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Closure, Atrial Arrhythmia
- Trial name
- ENLIgHT (NCT06293430)
- Testing
- VERAFEYE System
- Volunteers
- 50 people
- Sponsor
- LUMA Vision Ltd.
Atrial Fibrillation (AF), Stroke
Elite AF IDE Trial (Elite AF)
The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for…
- Trial name
- NCT07287436
- Testing
- WATCHMAN Elite LAAC Device
- Where
- 2 sites in United States
- Volunteers
- 400 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Stroke
Impact of Steerable Delivery Sheaths on Successful Closure of LA A With AMULET
The novel Amplatzer steerable delivery sheath (Abbott Vascular) is found to be safe and effective in performing LAAO procedure. However, the procedural outcomes have not been compared with the traditional non-steerable fixed…
- Trial name
- NCT05464511
- Testing
- Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.
- Where
- 7 sites in United States
- Volunteers
- 300 people
- Sponsor
- Kansas City Heart Rhythm Research Foundation
Coronary Artery Disease
Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure
Clinical investigation with CE-marked medical devices, multicenter, prospective, randomized and controlled. Patients with non-valvular atrial fibrillation at high embolic risk and with at least one high bleeding risk criterion…
- Trial name
- CALAMBRE (NCT07260474)
- Testing
- Patients implanted with Amplatzer Amulet™, Patients implanted with LAmbre™
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- Fundación EPIC
Atrial Fibrillation
Assessing the Safety and Efficacy of the LAmbre™ Plus Device
Randomized controlled trial assessing the safety and efficacy of the LAmbre Plus LAA Closure System to rescue the risk of thromboembolism in patients with non-valvular AF.
- Trial name
- REDUCE-AF (NCT06465706)
- Testing
- LAmbre investigational device
- Volunteers
- 1,826 people
- Sponsor
- Kansas City Heart Rhythm Research Foundation
Nonvalvular Atrial Fibrillation
TEE-Guided Versus CCTA-Guided Preprocedural Imaging for Left Atrial Appendage Closure
This prospective, open-label, multicenter randomized controlled trial will compare two preprocedural imaging assessment strategies in adults with nonvalvular atrial fibrillation who are scheduled to undergo percutaneous left…
- Trial name
- PEARL-LAAC (NCT07815119)
- Testing
- Transesophageal Echocardiography-Guided Preprocedural Assessment, Cardiac Computed Tomography Angiography-Guided Preprocedural Assessment
- Where
- China
- Volunteers
- 590 people
- Sponsor
- Shanghai Zhongshan Hospital
Concomitant Procedures, Atrial Fibrillation
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and…
- Conditions
- Concomitant Procedures, Atrial Fibrillation, PFA, LAAC
- Trial name
- OPTION-A (NCT06686485)
- Testing
- FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
- Where
- 37 sites in China, Hong Kong and 4 more
- Volunteers
- 433 people
- Sponsor
- Boston Scientific Corporation