Left Atrial Appendage Closure With SentreHeart Lariat® Device "Lariat"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed Description

The study cohort will consist of up to 50 patients who are candidates for 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.
Subjects consented will be tracked by the study team and will be considered enrolled in this study at the time of the start of their left atrial appendage closure procedure. All subjects that are consented who do not undergo left atrial appendage closure with SentreHeart Lariat® will be considered screen failures. Any patients that have a failed attempt at left atrial appendage closure with SentreHeart Lariat® will be tracked through their index hospitalization for safety; their study follow up will be complete at the time of discharge.
The invasive procedure for placement of the study devices will proceed according to standard interventional techniques, as already in place at the participating centers. Patients undergoing the Lariat® procedure will be administered colchicine 0.6 mg po twice daily for a minimum of three days preoperatively, and 30 days postoperatively. (This dose may be adjusted for renal function or intolerance).
Patients will undergo follow-up visits at 7 days, 90 days, and 180 days post procedure.

Conditions

Interventions

  • Left atrial appendage closure Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: SentreHeart Lariat
    Description: Left atrial appendage closure with SentreHeart Lariat device
  • SentreHeart Lariat® Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: SentreHeart Lariat
    Description: Left atrial appendage closure with SentreHeart Lariat device

Trial Design

  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of Participants with Successful Stand-Alone Left Atrial Appendage Closure Using SentreHeart Lariat Device as Measured by Left Atrial Appendage Closure Rates 4 Years Yes
Secondary Number of Participants with Adverse Events as a Measure of Safety and Tolerability 4 Years Yes

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