Left Atrial Appendage Closure With SentreHeart Lariat® Device

NCT ID: NCT02681042

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-05-02

Brief Summary

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

Cardioembolic Stroke; Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SentreHeart Lariat

Left atrial appendage closure with SentreHeart Lariat device

Group Type: EXPERIMENTAL

Left atrial appendage closure

Intervention Type: 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®

Intervention Type: 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.

Interventions

Left atrial appendage closure

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.

Intervention Type: PROCEDURE

SentreHeart Lariat®

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥18 years
• Patients able and willing to provide informed consent
• Documentation of atrial fibrillation or atrial flutter
• Clinical decision by the subject's physician that the patient is at risk for embolic stroke, and oral anticoagulant medications (OAC) is contraindicated
• Hypertension, Abnormal renal and hepatic function, Stroke, Bleeding tendency/predisposition, Labile International Normalized Ratios (INRs) on warfarin (HAS-BLED) score > 3
• Congestive Heart Failure (CHF), Hypertension, Age >65, Diabetes Mellitus, Stroke or Transient Ischemic Attack (TIA), Vascular Disease, Age >75, Sex Category (CHADS2-VASC) score >3, OR CHADS2-VASC of 2 if physician provides justification for procedure
• Anatomy favorable for deployment of the SentreHeart Lariat®

Exclusion Criteria

• Medically unable to provide informed consent
• Previous cardiothoracic surgery
• Patient is a candidate for catheter or surgical ablation
• Need for concomitant cardiac surgery procedure
• Thrombus in the left atrial appendage or left atrium
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J. B. DeVille, MD

Role: PRINCIPAL_INVESTIGATOR

Prinicpal Investigator

Locations

Baylor Research Institute at The Heart Hospital Baylor Plano

Plano, Texas, United States

Countries

United States

Other Identifiers

014-292

Identifier Type: -

Identifier Source: org_study_id