Laminar_CL-0059_LAMINAR LAAX

What is the Purpose of this Study?

The purpose of this study is to compare the safety and efficacy of the Laminar System (Investigational device) to commercially available left atrial appendage closure (LAAC) devices, such as Watchman FLX and Amulet (Control devices) in patients with non-valvular atrial fibrillation (NVAF) who are deemed appropriate for LAAC to reduce the risk of stroke and systemic embolism.


Eligibility

  • 1. Documented NVAF, defined as AF (paroxysmal, persistent, or permanent) in the absence of moderate-to-severe mitral stenosis or a mechanical heart valve.
  • 2. Subject ≥18 years old.
  • 3. CHA2DS2-VASc score ≥ 2 in men and ≥ 3 in women.
  • 4. Subject deemed appropriate for LAA closure by the Site Investigator and a clinician not a part of the procedural team using an evidenced based decision-making tool.
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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