Back to resultsEvaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System
Primary Purpose
Atrial Fibrillation
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Left Atrial Appendage Closure
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Left Atrial Appendage Closure
Eligibility Criteria
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.
Sites / Locations
- Israeli-Georgian Medical Research Clinic Helsicore
- Tbilisi Heart and Vascular Clinic
- Sanatorio Italiano Hospital
- Hospital de Clinicas San Lorenzo, National University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
Freedom from device or procedure related serious adverse events
Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE
Secondary Outcome Measures
Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04807283
Brief Title
Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
November 26, 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laminar, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Left Atrial Appendage Closure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Left Atrial Appendage Closure
Other Intervention Name(s)
Left Atrial Appendage Occlusion
Intervention Description
Closure or occlusion of the left atrial appendage to reduce the risk of thromboembolism in patients with NVAF
Primary Outcome Measure Information:
Title
Freedom from device or procedure related serious adverse events
Time Frame
7 days
Title
Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE
Time Frame
45 days
Secondary Outcome Measure Information:
Title
Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism
Time Frame
45 days and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Israeli-Georgian Medical Research Clinic Helsicore
City
Tbilisi
Country
Georgia
Facility Name
Tbilisi Heart and Vascular Clinic
City
Tbilisi
Country
Georgia
Facility Name
Sanatorio Italiano Hospital
City
Asunción
Country
Paraguay
Facility Name
Hospital de Clinicas San Lorenzo, National University
City
San Lorenzo
Country
Paraguay
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System
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