N/A
Completed N=9
Left Atrial Appendage Closure With SentreHeart Lariat® Device
Cardioembolic Stroke · Atrial Fibrillation
Source: ClinicalTrials.gov NCT02681042 ↗
Enrolled (actual)
9
Serious AEs
22.2%
Results posted
Feb 2026
Primary outcomePrimary: Number of Participants With Successful Stand-Alone Left Atrial Appendage Closure Using SentreHeart Lariat Device as Measured by Left Atrial Appendage Closure Rates — 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Stand-Alone Left Atrial Appendage Closure Using SentreHeart Lariat Device as Measured by Left Atrial Appendage Closure Rates |
6 | — |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
6 | — |
| SECONDARY Successful LAA Closure Rate |
6 | — |
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
Data sourced from ClinicalTrials.gov (NCT02681042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.