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

NCT04807283 | Unknown DMC FDA Device

• 1 other identifier: CL-0017
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 4

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).

Conditions

Atrial Fibrillation

Keywords

Left Atrial Appendage Closure

Outcome Measures

Primary Outcomes (2)

• Freedom from device or procedure related serious adverse events

  7 days

• Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE

  45 days

Secondary Outcomes (1)

• Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism

  45 days and 6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Device: Left Atrial Appendage Closure

Interventions

Left Atrial Appendage Closure DEVICE

Closure or occlusion of the left atrial appendage to reduce the risk of thromboembolism in patients with NVAF

Also known as: Left Atrial Appendage Occlusion

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Subject who requires anticoagulation for a condition other than AF.
• \. Subject with a New York Heart Association (NYHA) classification equal to IV.
• \. 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.
• \. Subject with valvular disease.

Sponsors & Collaborators

• Laminar, Inc.: lead

Study Sites (4)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

Location

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Location

Sanatorio Italiano Hospital

Asunción, Paraguay

Location

Hospital de Clinicas San Lorenzo, National University

San Lorenzo, Paraguay

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: March 5, 2021
• Primary Completion: November 26, 2021
• Study Completion: December 1, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GE (2); PA (2)