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

Atrial Fibrillation Clinical Trial

Official title:

A European Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04807283
• Other study ID #: CL-0017
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Laminar, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: December 2023
• Est. primary completion date: November 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Left Atrial Appendage Closure
Closure or occlusion of the left atrial appendage to reduce the risk of thromboembolism in patients with NVAF

Locations

Country	Name	City	State
Georgia	Israeli-Georgian Medical Research Clinic Helsicore	Tbilisi
Georgia	Tbilisi Heart and Vascular Clinic	Tbilisi
Paraguay	Sanatorio Italiano Hospital	Asunción
Paraguay	Hospital de Clinicas San Lorenzo, National University	San Lorenzo

Sponsors (1)

Lead Sponsor	Collaborator
Laminar, Inc.

Countries where clinical trial is conducted

Georgia,  Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from device or procedure related serious adverse events		7 days
Primary	Confirmation of functional LAA closure as defined by residual peri-device flow = 5mm per TEE		45 days
Secondary	Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism		45 days and 6 months