Clinical trials: Left Atrial Appendage Occluder
Left Atrial Appendage Occlusion
LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs
The objective of this trial is to compare two different commercially available left atrial appendage occlusion (LAAO) devices in patients with non-valvular Atrial fibrillation/ atrial flutter (AF) at increased risk for stroke…
- Trial name
- AMPIRI (NCT06060912)
- Testing
- Left Atrial Appendage Occlusion
- Where
- Germany
- Volunteers
- 226 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Atrial Fibrillation (AF), Stoke
Abbott Medical - VERITAS Study
The primary objective of this study is to evaluate the safety and effectiveness of Abbott's Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients who have non-valvular atrial fibrillation and who are…
- Trial name
- NCT06707688
- Testing
- Amulet™ 2 Left Atrial Appendage (LAA) Occluder
- Where
- 35 sites in United States, Belgium and 7 more
- Volunteers
- 458 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation
Left atrial appendage (LAA) occlude devices are used for over ten years. According to current data efficiency and safety of this approach at least comparable with pharmacological prevention of stroke in patients with non-valvular…
- Trial name
- NCT03867227
- Testing
- left atrial appendage occluder implantation
- Where
- Russia
- Volunteers
- 300 people
- Sponsor
- National Research Center for Preventive Medicine
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
Stroke
AMPLATZER™ Amulet™ LAA Occluder Trial
The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial…
- Trial name
- Amulet IDE (NCT02879448)
- Testing
- Amulet Left Atrial Appendage Occluder, WATCHMAN Left Atrial Appendage Closure
- Where
- 115 sites in United States, Australia and 9 more
- Volunteers
- 1,878 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Lifetech LAmbre™ Left Atrial Appendage Closure System Post-Market Registry
Single-center, single-arm, prospective, post-market study of LAmbre™ LAA Closure System. To evaluate immediate and long term procedural success of Lifetech LAmbre™ occluders in patients.
- Trial name
- NCT04307927
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Nonvalvular Atrial Fibrillation
First in Man Study of Left Atrial Appendage Pulsed Field Ablation Occluder
This is the first in man study of E-SeaLATM developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can achieve pulsed field ablation and mechanical closure of the Left Atrial Appendage simultaneously, this…
- Trial name
- NCT05731882
- Testing
- E-SeaLA, CardioPulse PFA system
- Where
- 3 sites in China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd
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, Anticoagulants and Bleeding Disorders
Left Atrial Appendage Occlusion for AF Patients Unable to Use Oral Anticoagulation Therapy
Up to 5% of Atrial Fibrillation (AF) patients may have or develop contraindications to use oral anticoagulation (OAC). Randomized controlled trial (RCT) data suggest that Left Atrial Appendage Occlusion (LAAO) may provide a…
- Trial name
- COMPARE-LAAO (NCT04676880)
- Testing
- Left atrial appendage occlusion (Watchman FLX or Amplatzer Amulet)
- Where
- 14 sites in Netherlands
- Volunteers
- 609 people
- Sponsor
- R&D Cardiologie
Atrial Fibrillation
Impact of Implantation of an LAA Occluder on ANP and BNP Level and Quality of Life
Closure of the LAA by several devices is a alternative therapy to oral anticoagulation in patients with Atrail fibrillation. Nothing is known about the acute influence of a device closure of the LAA on the secretion of ANB nad…
- Trial name
- NCT03085667
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- University of Leipzig
Atrial Fibrillation
Omega™ Left Atrial Appendage (LAA) Occluder in Patients With Non-Valvular Atrial Fibrillation
Atrial fibrillation is associated with increased risk of stroke mostly because of clot formation in the left atrial appendage, a small alcove in the left atrium heart chamber.
- Trial name
- NCT03526471
- Testing
- Omega™ Left Atrial Appendage (LAA) Occluder
- Where
- 2 sites in Denmark, Thailand
- Volunteers
- 20 people
- Sponsor
- Vascular Innovations Co. Ltd.
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 (LAA) Occluders After Catheter Ablation of Atrial Fibrillation
The primary objective of this study is to assess combined end point (All stroke, Systemic embolism, Cardiovascular death) between two groups.
- Trial name
- NCT01695824
- Testing
- LAA occluder, RFA ablation, Warfarin
- Where
- Russia
- Volunteers
- 96 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Atrial Fibrillation, Thromboembolism
AMPLATZER™ LAA Occluder Post Approval Study (PAS)
The aim of this multicenter, non-randomized observational post-approval is to compile real world outcome data on the use of an AMPLATZER LAA Occluder in subjects with non-valvular atrial fibrillation (NVAF).
- Conditions
- Atrial Fibrillation, Thromboembolism, Stroke
- Trial name
- NCT02964208
- Testing
- AMPLATZER™ LAA Occluder
- Where
- 22 sites in Argentina, Belgium and 5 more
- Volunteers
- 520 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Evaluation of the Safety and Efficacy of a Novel SeaLA™ Left Atrial Appendage Occluder
This study adapted a prospective, multicenter single-group objective performance criteria design. A total of 163 patients with non-valvular atrial fibrillation were enrolled in the clinical trial，follow up were scheduled in 7…
- Trial name
- NCT05911685
- Testing
- SeaLA™ left atrial appendage occluder
- Where
- China
- Volunteers
- 163 people
- Sponsor
- Hangzhou Dinova EP Technology Co., 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
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, Stroke
Left-Atrium-Appendage Occluder Register - GErmany
Evaluation of safety and effectiveness of implantable LAA occluder in clinical practice Indication: For which reasons is the indication for implantation of LAA-Occluder put for patients with atrial fibrillation? Safety: How save…
- Trial name
- LAARGE (NCT02230748)
- Where
- 4 sites in Germany
- Volunteers
- 643 people
- Sponsor
- Stiftung Institut fuer Herzinfarktforschung
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.
Left Atrial Appendage Occluder, Device Embolisation
Therapy Strategies After LAA Occluder Device Embolization
The investigators thought to evaluate risk factors, therapeutic approaches and outcomes after left atrial appendage occluder device embolization (LAAO, either surgical or interventional).
- Conditions
- Left Atrial Appendage Occluder, Device Embolisation, Therapy Strategies, Risk Factors
- Trial name
- LAAODE (NCT05014477)
- Testing
- Removal or leaving of LAA occluders
- Where
- Germany
- Volunteers
- 400 people
- Sponsor
- Cardiovascular Center Frankfurt