Clinical trials: Left Atrial Appendage Closure
Atrial Fibrillation, Arrhythmias, Cardiac
Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion
This study is a prospective, multi-center, randomized controlled trial. The subjects are patients scheduled to undergo a combined procedure of atrial fibrillation (AF) ablation and left atrial appendage (LAA) occlusion.
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT06455644
- Testing
- CT group, DSA group
- Where
- 5 sites in China
- Volunteers
- 238 people
- Sponsor
- First Affiliated Hospital of Shantou University Medical College
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
Non-valvular Atrial Fibrillation
Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology
The aim of the registry is to evaluate Chinese real-World clinical outcomes in patients With AF using the WATCHMAN left Atrial appendage closure technology
- Trial name
- RECORD (NCT03917563)
- Testing
- WATCHMAN LAA occluder
- Where
- China
- Volunteers
- 1,050 people
- Sponsor
- Xijing Hospital
Atrial Fibrillation
Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical Therapy
The study goal is to determine the clinical benefit of percutaneous catheter-based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) at high risk of stroke (CHA2DS2-VASc Score ≥2) as…
- Trial name
- CLOSURE-AF (NCT03463317)
- Testing
- CE-mark approved LAA closure devices, Acetylsalicylic acid, Clopidogrel
- Where
- 42 sites in Germany
- Volunteers
- 912 people
- Sponsor
- Charite University, Berlin, Germany
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
Device Occlusion
Feasibility and Prognosis of Left Atrial Appendage Closure in Patients With Heart Failure and Atrial Fibrillation
Study hypotheses is that in patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefore a higher rate of stroke and embolism are observed…
- Trial name
- LAAOHF (NCT04472871)
- Testing
- Left atrial appendage closure
- Volunteers
- 300 people
- Sponsor
- Assiut University
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.
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Atrial Fibrillation TRIal of Left Atrial Appendage Closure Using Seralene Hemostatic Suture
Atrial fibrillation is a common heart rhythm disorder that increases the risk of stroke. In patients with atrial fibrillation, blood clots most often form in a small structure of the heart called the left atrial appendage.
- Conditions
- ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF), Mitral Valve Surgery, Stroke (in Patients With Atrial Fibrillation)
- Trial name
- ATRI-LASH (NCT07360899)
- Testing
- LAA closure using the AtriLASH
- Where
- Serbia
- Volunteers
- 200 people
- Sponsor
- Institute of Cardiovascular Diseases, Vojvodina
Left Atrail Appendage Closure: Peri-device Leaks
Multimodality Evaluation of LAA Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry
Closure of peri-device leaks (PDL) after incomplete LAAC have shown early feasibility, however no comparison study of all the leak closure modalities exists.
- Trial name
- NCT05131308
- Testing
- leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Kansas City Heart Rhythm Research Foundation
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
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.
Left Atrial Appendage Occlusion, Antiplatelet Therapy
Head-to-head Comparison of Single Versus Dual Antiplatelet Treatment Strategy After Percutaneous Left Atrial Appendage Closure: a Multicenter, Randomized Study
The study will perform a randomized, head-to-head comparison between SAPT (aspirin) and DAPT (aspirin plus clopidogrel) after percutaneous LAA closure with implantation of the Amulet device (AbbottTM, Abbott Park, Illinois, US)…
- Trial name
- ARMYDA-AMULET (NCT05554822)
- Testing
- Aspirin 100mg, Aspirin 100 mg OD plus clopidogrel 75 mg OD
- Where
- 19 sites in Italy
- Volunteers
- 574 people
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
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
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.
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
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 (AF)
Medical and Surgical Hybrid Treatment of Atrial Fibrillation.
The objective of the study is to investigate the feasibility of a hybrid procedure removal of the atrial fibrillation. This is a single procedure for both surgical epicardial by minimally invasive route (Thoracoscopy) without…
- Trial name
- HT2AF (NCT02630914)
- Testing
- The AtriCure Synergy Ablation System
- Where
- France
- Volunteers
- 12 people
- Sponsor
- University Hospital, Toulouse
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, 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.
Cardiovascular Disease
A New Operation for the Treatment for Long-standing Atrial Fibrillation
Atrial fibrillation(AF) often occurs in patients with mitral valve disease. Both mitral replacement and mitral valve plasty are the effective methods to the mitral valve disease.
- Trial name
- ANOLAF (NCT03347695)
- Testing
- Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients), Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Fujian Medical University