Clinical trials: Left Atrial Appendage Occluder
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
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
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, 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
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
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 Fibrillation, Stroke
Feasibility and Safety Study of LAmbre Left Atrial Appendage Occluder
This study mainly evaluated the feasibility and safety of LAmbre Left Atrial Appendage Occluder which is to prevent ischemic stroke caused by atrial fibrillation(AF).
- Trial name
- NCT01920412
- Testing
- LAmbre Left Atrial Appendage(LAA) Occluder
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Non-Valvular Atrial Fibrillation
Evaluation of Safety and Performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk
The purpose of the study is to assess the safety and performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in LAA (Left Atrial Appendage) closure for patients with non-valvular atrial…
- Trial name
- Omega (NCT04829929)
- Testing
- Omega™LAA Occluder implantation
- Where
- 13 sites in Denmark, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Eclipse Medical Ltd.
Atrial Fibrillation
Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage (LAA) in Patients With Atrial Fibrillation
This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA occluder indicated for percutaneous LAA closure in adult male or female patients with atrial fibrillation.
- Trial name
- OLAAC (NCT02105584)
- Testing
- Implantation of LAA closure device
- Where
- 7 sites in Germany, United Kingdom
- Volunteers
- 78 people
- Sponsor
- Occlutech International AB
Atrial Fibrillation, Stroke
Amulet™ ADVANCE LAA
This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. Over 600 subjects have been enrolled at 16 US clinical sites.
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- NCT05997446
- Testing
- Left atrial appendage occlusion (LAAO)
- Where
- 16 sites in United States
- Volunteers
- 610 people
- Sponsor
- Abbott Medical Devices