Laminar Left Atrial Appendage Elimination Pivotal IDE Study

What is the Purpose of this Study?

The purpose of this study is to compare the safety and effectiveness of an experimental device called the Laminar Left Atrial Appendage Closure System with a commercially available left atrial appendage closure device that is used to close off the left atrial appendage to eliminate a potential source of blood clots. The study focuses on people who have atrial fibrillation, a condition in which the heart beats with an irregular rhythm. This irregular rhythm increases the chance of blood pooling and clotting inside the heart; the blood clots can break loose from the heart and cause a stroke. Previous research has shown that closing the heart outpouching (left atrial appendage) eliminates the area where blood clots can form, ultimately lowering the chance of a stroke occurring. Closing the left atrial appendage using the Laminar investigational device or a commercially approved device is the main procedure of the study. Participants will be randomly assigned to 1 of 2 groups. Group 1 will receive the Laminar Left Atrial Appendage Closure Device, and Group 2 will receive a commercially available left atrial appendage closure device.


Eligibility

  • * Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (NVAF)
  • * CHA2DS2-VASc score greater than or equal to (\>=) 2 in men and \>= 3 in women
  • * Deemed to be clinically indicated for left atrial appendage (LAA) closure by the Site Investigator and a clinician not a part of the procedural team using an evidence-based decision-making tool in accordance with standard of care
  • * Recommended for chronic oral anticoagulation therapy (OAC) but has an appropriate rationale to seek a non-pharmacologic alternative
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Laminar Left Atrial Appendage Elimination Pivotal IDE Study

Study Details
Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III

IRB Number

STUDY00003733

ClinicalTrials.gov ID

NCT06168942

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III

IRB Number

CL-0059

ClinicalTrials.gov ID

NCT06168942

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org