A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination
Purpose
The purpose of this study is to compare the safety and effectiveness of Laminar Left Atrial Appendage Closure (LAAC) device as compared to the commercially available LAAC devices in participants with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke (blocked blood vessel or bleeding in brain) and systemic embolism (blockage in a blood vessel harming vital organs).
Conditions
- Non-valvular Atrial Fibrillation
- Stroke
- Systemic Embolism
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (NVAF) - CHA2DS2-VASc score greater than or equal to (>=) 2 in men and >= 3 in women - Deemed to be clinically indicated for left atrial appendage (LAA) closure by the Site Investigator and a clinician not a part of the procedural team using an evidence-based decision-making tool in accordance with standard of care - Recommended for chronic oral anticoagulation therapy (OAC) but has an appropriate rationale to seek a non-pharmacologic alternative - Eligible for the protocol-specified post-procedural antithrombotic regimen - Willing and able to comply with the protocol, and has provided written informed consent (participant or legally authorized representative) per institutional review board (IRB) requirements
Exclusion Criteria
- Single episode, transient, or reversible atrial fibrillation (AF) (example, secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures) - Prior cardiac surgery or any procedure that involved pericardial access - Stage IV kidney disease or Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) less than (<) 30 milliliters per minute per (mL/min)/1.73 square meters (m^2) or participants with end stage renal disease who are dialysis dependent - Any cardiac or non-cardiac interventional or surgical procedures within 60 days prior to or any planned general surgery, cardiac surgery, or interventional procedure within 60 days after implant (including, but not limited to cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery) - Left atrial appendage anatomy which cannot accommodate either commercially available control device or the laminar implant per manufacturer instructions for use (IFU) (that is, the anatomy and sizing must be appropriate for a control and the Laminar device to be enrolled in the study)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Laminar Device |
Participants will be treated with the Laminar Left Atrial Appendage Closure System. |
|
|
Active Comparator Control left atrial appendage closure (LAAC) |
Participants will be treated with a commercially-available LAAC device. |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Biosense Webster, Inc.
Detailed Description
This prospective, randomized, controlled, multicenter, open-label pivotal clinical study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternative. Participants will be randomized 1:1 to the Laminar Left Atrial Appendage Closure System or commercially available device (WATCHMAN™ left atrial appendage closure device / Amulet™ left atrial appendage occluder).