An interventional study of Left atrial appendage closure and SentreHeart Lariat® in Cardioembolic Stroke and Atrial Fibrillation, sponsored by Baylor Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Baylor Research Institute · Not applicable, Interventional, and Prevention
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.
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.
40 studies on the registry are indexed under Embolic Stroke; 11 are open to participants now.
This study's enrollment of 9 is below the median of 197 across 13 interventional studies indexed under Embolic Stroke.
Browse Embolic Stroke studies →Baylor Research Institute is the lead sponsor of 223 studies on the registry; 48 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Left atrial appendage closure with SentreHeart Lariat device
Procedure: Left atrial appendage closure · Device: 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.
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.
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
Time frame: 180 days
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Secondary aims include assessment of adverse events
Time frame: 180 days
Successful LAA Closure Rate
Secondary aims include successful LAA closure rates
Time frame: 180 days
Patients were recruited from 4 different hospitals.
| Milestone | SentreHeart Lariat |
|---|---|
| Started | 9 |
| Completed | 6 |
| Not completed | 3 |
| Withdrew: Implant failure | 3 |
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
| Participants | SentreHeart Lariat |
|---|---|
| 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 aims include assessment of adverse events
| patients with adverse events | SentreHeart Lariat |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 6 |
Secondary aims include successful LAA closure rates
| Participants | SentreHeart Lariat |
|---|---|
| Successful LAA Closure Rate | 6 |
Collected over 180 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SentreHeart Lariat | 0/9 (0%) | 2/9 (22.2%) | 6/9 (66.7%) |
| Event | SentreHeart Lariat |
|---|---|
| Atrial FibrillationCardiac disorders | 1/9 |
| Positive nuclear stress testCardiac disorders | 1/9 |
| Event | SentreHeart Lariat |
|---|---|
| hypotensionCardiac disorders | 2/9 |
| diarrheaGastrointestinal disorders | 1/9 |
| UTIRenal and urinary disorders | 1/9 |
| pericardial effusionCardiac disorders | 1/9 |
| unspecified chest painCardiac disorders | 1/9 |
| bilateral pleural effusionRespiratory, thoracic and mediastinal disorders | 1/9 |
9 patients were enrolled and had the the Sentreheart device implantation attempted
| Age, Categorical(Participants) | SentreHeart Lariat |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 7 |
| Age, Continuous(years) | SentreHeart Lariat |
|---|---|
| Mean | 73.6 (58 to 88) |
| Sex: Female, Male(Participants) | SentreHeart Lariat |
|---|---|
| Female | 5 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | SentreHeart Lariat |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | SentreHeart Lariat |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | SentreHeart Lariat |
|---|---|
| United States | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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