Status:
SUSPENDED
A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Non-valvular Atrial Fibrillation
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 29 2032
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06168942
Start Date
February 19 2024
End Date
February 29 2032
Last Update
December 19 2025
Active Locations (70)
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1
Grandview Medical Center
Birmingham, Alabama, United States, 35243
2
Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG
Phoenix, Arizona, United States, 85018
3
Tucson Medical Center
Tucson, Arizona, United States, 85712
4
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72401