Status:
UNKNOWN
Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System
Lead Sponsor:
Laminar, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04807283
Start Date
March 5 2021
End Date
December 1 2023
Last Update
October 3 2023
Active Locations (4)
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1
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia
2
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
3
Sanatorio Italiano Hospital
Asunción, Paraguay
4
Hospital de Clinicas San Lorenzo, National University
San Lorenzo, Paraguay