Clinical trials: Left Atrial Appendage Occlusion
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, Percutaneous Coronary Intervention
LAAO Versus NOAC in Patients with AF and PCI
Atrial fibrillation (AF) coincides with coronary artery disease (CAD) shared common risk factors and pathophysiologic pathways. CAD affects approximately 25% of AF patient according to the trial Atrial Fibrillation Follow-up…
- Trial name
- NCT05353140
- Testing
- The WATCHMAN/WATCHMAN FLX device, Rivaroxaban + Clopidogre, Aspirin + Clopidogrel
- Where
- China
- Volunteers
- 1,386 people
- Sponsor
- Xijing Hospital
Coronary Artery Disease, Stroke
Effects of Left Atrial Appendage Resection and Marshall Ligament Amputation on Clinical Outcome in Patients Undergoing Off-pump Coronary Artery Bypass
Surgical occlusion of the left atrial appendage (LAAO) is sometimes performed during the cardiac surgery to reduce long-term risk of stroke.A previous study found that LAAO may be associated with increased risk of postoperative…
- Conditions
- Coronary Artery Disease, Stroke, Atrial Fibrillation
- Trial name
- NCT04220047
- Testing
- Left Atrial Appendage Resection and Marshall Ligament Amputation
- Where
- China
- Volunteers
- 400 people
- Sponsor
- China National Center for Cardiovascular Diseases
Atrial Fibrillation
Russian National Registry of LAAO
The first Russian registry presents data from two hundred consecutive patients with nonvalvular atrial fibrillation, who undergone left atrial appendage occlusion (LAAO) using the Watchman device and the Amplatzer cardiac plug.
- Trial name
- NCT04322474
- Testing
- Catheter-based left atrial appendage occlusion
- Volunteers
- 200 people
- Sponsor
- National Research Center for Preventive Medicine
Atrial Fibrillation
Left Atrial Appendage Occlusion Registry (LAAO Registry)
The Left Atrial Appendage Occlusion Registry (LAAO Registry™) is designed to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous and epicardial based left atrial appendage occlusion…
- Trial name
- NCT02699957
- Testing
- Left Atrial Appendage Occlusion
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- American College of Cardiology
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
Cardiac Surgery
Evaluation of Cardiac Hemodynamic Modifications During Temporary Left Atrial Appendage Occlusion
The left atrium appendage (LAA) is a remnant of the original embryonic left atrium formed during the third week of gestation. LAA is believed to function as a decompression chamber during left ventricular systole and other…
- Trial name
- NCT02814851
- Testing
- Transesophageal echocardiogram, Thermistor-tipped catheter, Pressure/volume catheter
- Where
- Belgium
- Volunteers
- 20 people
- Sponsor
- Brugmann University Hospital
Atrial Fibrillation, Aortic Stenosis
Comparison of Left Atrial Appendage Occlusion vs Standard Medical Therapy in Patients in AF Undergoing TAVI
Study category and Rationale Clinical study, Category A. Clinical Phase: Post market study Background and Rationale: Left atrial appendage occlusion (LAAO) allows avoiding oral anticoagulation and provides at the same time an at…
- Trial name
- TAVI/LAAO (NCT03088098)
- Testing
- LAAO
- Where
- Switzerland
- Volunteers
- 81 people
- Sponsor
- University of Zurich
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 Fibrillation
Platelet-activation and Optimal Inhibition in Patients With Atrial Fibrillation Undergoing Left Atrial Appendage Occlusion
The POPULAR-LAAO registry is an open-label observational prospective registry to investigate hemostatic processes following left atrial appendage occlusion.
- Trial name
- POPULAR-LAAO (NCT04705688)
- Where
- Netherlands
- Volunteers
- 120 people
- Sponsor
- R&D Cardiologie
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
Aortic Valve Disorder
Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage
Atrial fibrillation (AF) is a common comorbidity of patients candidates to transcatheter aortic valve implantation (TAVI). The management of chronic oral anticoagulation (OAC) for the prevention of ischemic stroke is very…
- Trial name
- TAVI-LAAC (NCT02678871)
- Testing
- Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations), WATCHMAN
- Where
- 6 sites in Germany, Italy and 2 more
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Atrial Fibrillation, Coronary Artery Disease
Safety and Efficacy of Left Atrial Appendage Closure Versus Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Drug-Eluting Stent Implantation Due to Complex Coronary Artery Disease
Comparatively analyze the safety and validity of Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure, and the medical treatment with dabigatran plus aspirin or dabigatran plus clopidogrel after…
- Trial name
- NCT02606552
- Testing
- Dabigatrain plus aspirin, Dabigatrain plus clopidogrel, Amplazter Cardiac Plug (ACP)
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- Yonsei University
Non-valvular Atrial Fibrillation
The CONFORMAL Early Feasibility Study
An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
- Trial name
- NCT03616028
- Testing
- left atrial appendage closure
- Where
- 11 sites in United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Conformal Medical, Inc
Atrial Fibrillation, Heart Diseases
Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis
Atrial fibrillation (AF) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (HD).
- Conditions
- Atrial Fibrillation, Heart Diseases, Renal Disease, Bleeding
- Trial name
- WATCH-HD (NCT03446794)
- Testing
- Non Intervention
- Where
- 20 sites in Spain
- Volunteers
- 300 people
- Sponsor
- Fundación EPIC
Atrial Fibrillation, Stroke
Hemostatic Activity Following LAAO
The primary objective of this study is to prospectively investigate hemostatic activity following transcatheter left atrial appendage occlusion (LAAO).
- Trial name
- NCT05011981
- Testing
- Left Atrial Appendage Occlusion
- Where
- Denmark
- Volunteers
- 135 people
- Sponsor
- University of Aarhus
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
Combined Pulsed-field Ablation (PFA)
Combined Pulsed-field Ablation (PFA) and Left Atrial Appendage Occlusion Using Watchman Flx or Amulet
AF ablation is an established treatment option for non-valvular atrial fibrillation (NVAF). While AF ablation helps to maintain cardiac rhythm in sinus, the stroke risk associated with AF persists after ablation.
- Trial name
- COMPAWA (NCT05560204)
- Testing
- Combined Pulsed-field Ablation (PFA) + Left Atrial Appendage Occlusion (LAAO)
- Where
- Hong Kong
- Volunteers
- 200 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Non Valvular Atrial Fibrillation
LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
Worldwide, atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. The prevalence of AF gradually increases with age; its prevalence is 0.5% ~ 0.8% among 45 ~ 59 year-olds, 1.8% ~ 5.9% among 60 ~ 69 year-olds…
- Trial name
- LAmbre2 (NCT07455539)
- Testing
- LAmbre II Left Atrial Appendage Occluder
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Atrial Fibrillation, Left Atrial Appendage Occlusion
Pulsed Field Ablation for Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion
This is a single-center, prospective, single-arm clinical trial designed to evaluate the safety and efficacy of pulsed field ablation (PFA) after left atrial appendage occlusion (LAAO) in patients with non-valvular atrial…
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Occlusion, Pulsed Field Ablation
- Trial name
- PFA after LAAO (NCT07313228)
- Testing
- Pulsed Field Ablation
- Volunteers
- 70 people
- Sponsor
- First Affiliated Hospital of Ningbo University