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

October 2, 2023 updated by: Laminar, Inc.

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Device: Left Atrial Appendage Closure
Closure or occlusion of the left atrial appendage to reduce the risk of thromboembolism in patients with NVAF
Other Names:
  • Left Atrial Appendage Occlusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from device or procedure related serious adverse events
Time Frame: 7 days
7 days
Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE
Time Frame: 45 days
45 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism
Time Frame: 45 days and 6 months
45 days and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laminar, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2021

Primary Completion (Actual)

November 26, 2021

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-0017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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