Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System

Laminar Pharma

Status: Active, not recruiting

Conditions: Atrial Fibrillation

Treatments: Device: Left Atrial Appendage Closure

Study type: Interventional

Funder types: Industry

Identifiers

NCT04807283

CL-0017

Details and patient eligibility

About

The objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism from the left atrial appendage (LAA).

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (AF).
• 2. Subject must be ≥18 years of age.
• 3. Subject has a calculated CHA2DS2-VASc score of 2 or greater.
• 4. Subject must be clinically stable on warfarin (or other anticoagulant) therapy for a minimum of three months.
• 5. Subject must have at least two International Normalized Ratios (INRs); 2-3, if on Warfarin.
• 6. Subject is eligible for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy.

Exclusion criteria

• 1. Subject who requires anticoagulation for a condition other than AF.
• 2. Subject with a New York Heart Association (NYHA) classification equal to IV.
• 3. Subject with a history of or implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device that would interfere with the investigational device placement.
• 4. Subject with valvular disease.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Treatment

Experimental group

Treatment:

Device: Left Atrial Appendage Closure