Clinical trials: Atrial Appendage
Atrial Fibrillation, Left Atrial Appendage
Zenith LAA Occlusion System
Demonstrate the safety and performance of the Zenith LAA Occlusion System and procedure to occlude the Left Atrial Appendage (LAA) from the left atrium (LA) using a minimally invasive technique.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage, Stroke
- Trial name
- NCT05951101
- Testing
- Zenith LAA Occlusion System
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 10 people
- Sponsor
- AuriGen Medical Ltd
Device Related Thrombosis, Peri-device Leak
Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics
The current standard of care for patients who underwent left atrial appendage closure (LAAC) is to have follow-up transesophageal echocardiogram (TEE) for device surveillance.
- Trial name
- NCT06523166
- Testing
- Transesophageal echocardiography (TEE), Cardiac CTA
- Where
- 5 sites in United States
- Volunteers
- 320 people
- Sponsor
- University Hospitals Cleveland Medical Center
Atrial Fibrillation, Left Atrial Appendage Thrombosis
Intracardiac Echocardiography Guided Watchman Device Implant
This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place the Watchman in patients.
- Trial name
- NCT06007872
- Testing
- Intracardiac Echocardiography (ICE)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- The Cleveland Clinic
Atrial Fibrillation
aMAZE Trial Continued Access Protocol
aMAZE CAP is an extension to the current aMAZE Trial investigation (IDEG150107/NCT02517397/Protocol Appendix 16) in the form of a nested, non-randomized registry, to allow ongoing treatment of subjects and the collection of…
- Trial name
- aMAZE CAP (NCT04468334)
- Testing
- LARIAT + PVI
- Where
- 25 sites in United States
- Volunteers
- 82 people
- Sponsor
- AtriCure, Inc.
Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation, LAA Anatomy Amenable to Treatment by Percutaneous Technique
Coherex WAVECREST I Left Atrial Appendage Occlusion Study
Purpose To establish the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage Occlusion System for left atrial appendage (LAA) closure during treatment of non-valvular atrial fibrillation in patients who are at…
- Conditions
- Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation, LAA Anatomy Amenable to Treatment by Percutaneous Technique, Anticoagulation Indication for Potential Thrombus Formation in the Left Atrium
- Trial name
- NCT02239887
- Testing
- WaveCrest LAA occlusion device
- Volunteers
- 155 people
- Sponsor
- Coherex Medical
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, 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
Persistent Atrial Fibrillation
WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm
WATCH-Rhythm is a prospective, randomized, multi-center, investigation to collect safety and effectiveness data on combining conventional AF ablation with LAA electric isolation and closure within a single procedure.
- Trial name
- WATCH-Rhythm (NCT03835338)
- Testing
- Pulmonary Vein Isolation, LAA Isolation, LAA Occlusion
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Stroke
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm.
- Trial name
- NCT00129545
- Testing
- WATCHMAN Left Atrial Appendage Closure Technology, Warfarin
- Where
- 62 sites in United States, Czechia and 1 more
- Volunteers
- 800 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Population
Cryoablation combined with left atrial appendage closure is a novel strategy for atrial fibrillation patients. Through long-term follow-up, the investigators aimed to observe the safety and efficacy of the combined procedure in…
- Trial name
- CLACBAC (NCT04185142)
- Testing
- cryoballoon ablation combining with left atrial appendage closure
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai 10th People's Hospital
Atrial Fibrillation, Stroke
Amplatzer Amulet LAAO vs. NOAC
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for…
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- CATALYST (NCT04226547)
- Testing
- Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder), Non-Vitamin K Oral Antagonists
- Where
- 127 sites in United States, Australia and 14 more
- Volunteers
- 2,650 people
- Sponsor
- Abbott Medical Devices
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
Non-valvular Atrial Fibrillation (NVAF)
FIM Study of the LAmbre™ II LAA Occluder in Non-Valvular AF Patients
To evaluate the preliminary safety and feasibility of the LAmbreTM II Left Atrial Appendage Occluder and the Occluder Delivery System in patients with non-valvular atrial fibrillation who are at increased risk for stroke and…
- Trial name
- NCT07385599
- Testing
- LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Fibrillation, Silent Stroke
Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion
The study aims to assess the effect of the use of neuroprotection in transcutaneous occlusion of the left atrial appendage in patients with atrial fibrillation on the risk of perioperative silent brain ischemia and associated…
- Conditions
- Atrial Fibrillation, Silent Stroke, Cognitive Impairment, Depression
- Trial name
- LAAC-SBI (NCT05369195)
- Testing
- LAAC procedure with the use of transcatheter cerebral protection system, LAAC procedure without the use of transcatheter cerebral protection system
- Where
- 6 sites in Poland
- Volunteers
- 240 people
- Sponsor
- Silesian Centre for Heart Diseases
Atrial Fibrillation
Clinical Investigation of the LAmbre Left Atrial Appendage Closure System
The aim of the study LA-EU-01 was to examine the safety and the feasibility of the LAmbreTM Left Atrial Appendage Closure System in patients with non-valvular paroxymal, persistent or permanent atrial fibrillation, by using…
- Trial name
- NCT03122028
- Testing
- LAA closure system
- Volunteers
- 61 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Left Atrial Appendage Absent
VCLIP Post-Market Study, Long-term Follow-up on LAA Exclusion Using AtriClip
Retrospective-prospective, multi-center, non-randomized, unblinded, post-market study to evaluate the long-term performance and safety of AtriClip® FLEX-V LAA and PRO•V LAA Exclusion devices for exclusion of the left atrial…
- Trial name
- VCLIP (NCT05101993)
- Testing
- AtriClip
- Where
- 11 sites in United States
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- AtriCure, Inc.
Heart Failure, Atrial Fibrillation (AF)
Bachmann Bundle Pacing for Prevention of New-Onset Atrial Fibrillation in Patients With Heart Failure
This is a multi-center, prospective, single-blind, randomized controlled clinical trial to evaluate the efficacy and safety of Bachmann bundle pacing (BBP) in preventing new-onset atrial fibrillation (AF) in patients with chronic…
- Conditions
- Heart Failure, Atrial Fibrillation (AF), Cardiac Insufficiency
- Trial name
- NCT07547449
- Testing
- Bachmann Bundle Pacing, Right Atrial Appendage Pacing
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Fu Wai Hospital, Beijing, China
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
Atrial Fibrillation, Thrombus; Embolism
Study on the Significance of Auricular Clip in Prevention and Treatment of Valvular Heart Disease Atrial Thrombosis
To evaluate the safety and clinical efficacy of left atrial appendage in the prevention of thrombus in patients with valvular heart disease, to improve the product according to clinical conditions, to achieve clinically accurate…
- Conditions
- Atrial Fibrillation, Thrombus; Embolism, Warfarin, Atrial Appendage
- Trial name
- NCT05263024
- Testing
- atrial appendage clip
- Volunteers
- 118 people
- Sponsor
- Second Affiliated Hospital of Nanchang University
Atrial Fibrillation
Comparison of Outcomes After Left Atrial Appendage Closure or Oral Anticoagulation in Patients With Atrial Fibrillation
The aim of the study is to compare intermedium-term clinical outcomes, including thromboembolic events and bleeding complications between patients with non-valvular atrial fibrillation treated with either oral anticoagulation or…
- Trial name
- NCT02787525
- Testing
- Questionnaire
- Volunteers
- 1,000 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern