Left Atrial Appendage Closure Device for Atrial Fibrillation

Recruiting in Palo Alto (17 mi)

+12 other locations

Overseen byWilliam Gray, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Conformal Medical, Inc

No Placebo Group

Trial Summary

What is the purpose of this trial?

An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion

Research Team

William Gray, MD

Principal Investigator

Main Line Health Lankenae Heart Institute

Eligibility Criteria

Adults with non-valvular atrial fibrillation who need but want to avoid long-term oral anticoagulation therapy. Candidates should have a CHA2DS2-VASc score of ≥2 for men or ≥3 for women, indicating a higher risk of stroke. They must be able to follow the study's procedures and provide consent. Exclusions include pregnancy, certain heart conditions, other investigational studies participation, life expectancy under 2 years, severe kidney issues, and allergies to specific medications or device materials.

Inclusion Criteria

I have a type of irregular heartbeat not caused by a heart valve issue.

I am at high risk for stroke, with a CHA2DS2-VASc score of 2 or more (men) or 3 or more (women).

I am advised to take blood thinners but need a non-drug alternative.

See 4 more

Exclusion Criteria

I am not pregnant or nursing and do not plan to become pregnant within a year.

Current participation in another investigational drug or device study

I am allergic to aspirin, heparin, nickel, titanium, gold, or certain medications.

See 27 more

Treatment Details

Interventions

Conformal Left Atrial Appendage Seal (Left Atrial Appendage Closure Device)

Trial OverviewThe trial is testing the safety and effectiveness of the Conformal Left Atrial Appendage Seal (CLAAS) as an alternative to chronic oral anticoagulation in preventing stroke in patients with atrial fibrillation. It involves implanting CLAAS via catheter-based system.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Non-valvular AF adultsExperimental Treatment1 Intervention

Left atrial appendage closure (LAAC) with the CLAAS device will be performed according to the device Instructions for Use, based on TEE, ICE and angiographic guidance, femoral venous access and inter-atrial septum crossing.