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

Not Applicable

Active, not recruiting

• Conditions: Atrial Fibrillation
• Interventions: Device: Left Atrial Appendage Closure

• Registration Number: NCT04807283
• Lead Sponsor: Laminar, Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-05
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-19
• Primary Completion: 2021-11-26
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Left Atrial Appendage Closure	-

Primary Outcome Measures

Name	Time	Method
Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE	45 days
Freedom from device or procedure related serious adverse events	7 days

Secondary Outcome Measures

Name	Time	Method
Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism	45 days and 6 months

Trial Locations

Locations (4)

Tbilisi Heart and Vascular Clinic; 🇬🇪 Tbilisi, Georgia

Israeli-Georgian Medical Research Clinic Helsicore; 🇬🇪 Tbilisi, Georgia

Hospital de Clinicas San Lorenzo, National University; 🇵🇾 San Lorenzo, Paraguay

Sanatorio Italiano Hospital; 🇵🇾 Asunción, Paraguay