A Prospective, Multicenter, Randomized, Active Controlled, Clinical Trial of the LAMax LAA Closure System Compared to the Watchman® LAAC Device for Subjects With Non-valvular Atrial Fibrillation to Reduce the Risk of Ischemic Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-valvular Atrial Fibrillation
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 236
- Locations
- 12
- Primary Endpoint
- Ischemic stroke, TIA, or Systemic embolism
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the LAMax Left Atrial Appendage (LAA) Closure System.
Detailed Description
This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the LAMax Left Atrial Appendage Closure (LAAC) System. Subjects with non-valvular Atrial Fibrillation will be randomized in a 1:1 ratio to the Experimental Treatment Arm (LAMax LAAC system) or the Control Arm (Watchman LAAC system, Boston Scientific Inc., USA). The trial is designed to demonstrate that safety and effectiveness of the LAMax device are non-inferior to the Watchman device.
Investigators
Jian'an Wang,MD,PhD
President of the Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology
Second Affiliated Hospital, School of Medicine, Zhejiang University
Eligibility Criteria
Inclusion Criteria
- •Patients ≥ 18 years old with non-valvular atrial fibrillation (AF) and CHA2DS2-VASc ≥2
- •There is one of the following: (1) Not suitable for long-term standard anticoagulation treatment; (2) On the basis of long-term standardized anticoagulant therapy with warfarin, stroke or embolism still occurred; (3) HAS-BLED ≥
- •Provide written informed consent and agree to comply with required follow-ups.
Exclusion Criteria
- •. Patients with other diseases other than AF who need long-term warfarin anticoagulation therapy;
- •. Those who need selective cardiac surgery;
- •. Heart failure NYHA grade IV;
- •. AF caused by rheumatic valvular disease, degenerative valvular disease, congenital valvular disease, severe mitral stenosis, aortic stenosis, or other valvular diseases;
- •. The early onset of AF and paroxysmal AF with definite causes, such as secondary to coronary artery bypass grafting (CABG), hyperthyroidism;
- •. Patients with symptomatic carotid artery disease (such as carotid stenosis \> 50%);
- •. Patients with acute myocardial infarction, unstable angina, or recent myocardial infarction \< 3 months;
- •. Stroke or TIA within 30 days;
- •. Bleeding disease, coagulation-related diseases, and active peptic ulcer;
- •. Active endocarditis, vegetations, or other infections causing bacteremia or sepsis;
Outcomes
Primary Outcomes
Ischemic stroke, TIA, or Systemic embolism
Time Frame: 12 months post-implantation
A composite rate of ischemic stroke, TIA or systemic embolism.
Successful sealing of the LAA
Time Frame: 12 months post-implantation
A composite rate of successful sealing of the left atrial appendage (defined as residual flow ≤ 5 mm) at the 12-month visit documented by transesophageal echocardiogram (TEE).
Secondary Outcomes
- All stroke, systemic embolism, or cardiovascular/unexplained death(12 months post-implantation)
- Success rate of device collapse and reposition during implantation procedure(0 day)
- Incidence of MACCE events(12 months post-implantation)
- Major Bleeding post-device implant(12 months post-implantation)
- Device performance post-implantation(12 months post-implantation)
- Device success rate(0 day)
- Rate of cardiac temponade during implantation procedure(0 day)
- Success rate of delivering an occlusion device to the LAA by the delivery system(0 day)
- Success rate of withdrawing a delivery system after LAAC(0 day)
- Perioperative clinical success rate(7 days post-implantation)