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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04807283
Other study ID # CL-0017
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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