NCT02681042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2018

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

February 6, 2026

Completed
Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

3.2 years

First QC Date

May 26, 2015

Results QC Date

May 20, 2024

Last Update Submit

January 21, 2026

Conditions

Cardioembolic StrokeAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Successful Stand-Alone Left Atrial Appendage Closure Using SentreHeart Lariat Device as Measured by Left Atrial Appendage Closure Rates

    The primary aim is to assess the outcome of patients undergoing left atrial appendage ligation or closure with the SentreHeart Lariat® device as a stand-alone procedure at the participating centers

    180 days

Secondary Outcomes (2)

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    180 days

  • Successful LAA Closure Rate

    180 days

Study Arms (1)

SentreHeart Lariat

EXPERIMENTAL

Left atrial appendage closure with SentreHeart Lariat device

Procedure: Left atrial appendage closureDevice: SentreHeart Lariat®

Interventions

Left atrial appendage closurePROCEDURE

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
SentreHeart Lariat®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.

SentreHeart Lariat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor Research Institute at The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Embolic StrokeAtrial Fibrillation

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Ischemic StrokeStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac CatheterizationCatheterizationTherapeuticsInvestigative Techniques

Results Point of Contact

Title
Dr. J Brian DeVille
Organization
Baylor Scott and White The Heart Hospital Plano
Brian.DeVille@BSWHealth.org
469-800-4540

Study Officials

  • J. B. DeVille, MD

    Prinicpal Investigator

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

February 12, 2016

Study Start

March 1, 2015

Primary Completion

May 2, 2018

Study Completion

May 2, 2018

Last Updated

February 6, 2026

Results First Posted

February 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)