Left Atrial Appendage Closure With SentreHeart Lariat® Device

Part of paid clinical trials in Plano, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT02681042
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Left atrial appendage closure — PROCEDURE
    The SentreHeart Lariat® device (that is approved for soft tissue ligation) will be used to ligate or close the left atrial appendage as a stand-alone procedure at the participating centers.
  • SentreHeart Lariat® — DEVICE
    The SentreHeart Lariat® device (that is approved for soft tissue ligation) will be used to ligate or close the left atrial appendage as a stand-alone procedure at the participating centers.

Study Details

The study cohort will consist of up to 50 patients who are candidates for Left Atrial Appendage (LAA) closure in whom oral anticoagulation is contraindicated. Subjects evaluated for left atrial appendage closure will be screened for inclusion and consented prior to their procedure. If the anatomy is favorable for placement of the Lariat® device, the procedure will be performed at one of the participating centers. If anatomy is not favorable, the patient will be excluded from the study and managed using best care practices by his or her physician.

Key Dates

Start date
Mar 31, 2015
Status verified
Jan 2026
Primary completion
May 2, 2018
Completion
May 2, 2018

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: SentreHeart Lariat
    Left atrial appendage closure with SentreHeart Lariat device

Primary Outcome Measure

Number of Participants With Successful Stand-Alone Left Atrial Appendage Closure Using SentreHeart Lariat Device as Measured by Left Atrial Appendage Closure Rates [ Time Frame: 180 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor Research Institute at The Heart Hospital Baylor PlanoPlanoTexas75093-

Find similar trials in Plano, TX

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Baylor Research Institute at The Heart Hospital Baylor Plano· Plano, TX

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