Clinical trial NCT02681042: Left Atrial Appendage Closure With SentreHeart Lariat® Device
Official title: Left Atrial Appendage Closure With SentreHeart Lariat® Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardioembolic Stroke
Atrial Fibrillation
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants with Successful Stand-Alone Left Atrial Appendage Closure Using SentreHeart Lariat Device as Measured by Left Atrial Appendage Closure Rates
timeFrame: 4 Years
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 4 Years
measure: Successful LAA closure rate
timeFrame: 4 years
Other outcomes:
Locations:
city: Plano
country: United States
facility: Baylor Research Institute at The Heart Hospital Baylor Plano
state: Texas
Study officials:
affiliation: Prinicpal Investigator
name: J. B. DeVille, MD
role: PRINCIPAL_INVESTIGATOR
References: