Left Atrial Appendage Closure With SentreHeart Lariat® Device
Completed · Not applicable
Conditions studied: Cardioembolic Stroke, Atrial Fibrillation
In brief
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 facts
- Study ID
- NCT02681042
- Run by
- Baylor Research Institute
- People needed
- 9
- Starts
- 2015-03-01
- Expected to finish
- 2018-05-02
- Last updated by the study team
- 2026-02-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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®
You may not qualify if…
- 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
Where it is running
- Baylor Research Institute at The Heart Hospital Baylor Plano — Plano, Texas, United States
Full record on ClinicalTrials.gov
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