Trial Outcomes & Findings for Left Atrial Appendage Closure With SentreHeart Lariat® Device (NCT NCT02681042)
NCT ID: NCT02681042
Last Updated: 2026-02-06
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
180 days
Results posted on
2026-02-06
Participant Flow
Patients were recruited from 4 different hospitals.
Patients were enrolled, but if the implant of the Lariat device was not successful, patients would be exited from the trial. All patients with successful implant were followed for 180 days.
Participant milestones
| Measure |
SentreHeart Lariat
Left atrial appendage closure with SentreHeart Lariat device
Left atrial appendage closure: 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®: 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.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
SentreHeart Lariat
Left atrial appendage closure with SentreHeart Lariat device
Left atrial appendage closure: 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®: 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.
|
|---|---|
|
Overall Study
Implant Failure
|
3
|
Baseline Characteristics
Left Atrial Appendage Closure With SentreHeart Lariat® Device
Baseline characteristics by cohort
| Measure |
SentreHeart Lariat
n=9 Participants
Left atrial appendage closure with SentreHeart Lariat device
Left atrial appendage closure: 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®: 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=41 Participants
|
|
Age, Continuous
|
73.6 years
n=41 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 180 daysThe 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
Outcome measures
| Measure |
SentreHeart Lariat
n=9 Participants
Left atrial appendage closure with SentreHeart Lariat device
Left atrial appendage closure: 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®: 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
|
6 Participants
|
SECONDARY outcome
Timeframe: 180 daysSecondary aims include assessment of adverse events
Outcome measures
| Measure |
SentreHeart Lariat
n=9 Participants
Left atrial appendage closure with SentreHeart Lariat device
Left atrial appendage closure: 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®: 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 Adverse Events as a Measure of Safety and Tolerability
|
6 patients with adverse events
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Number of patients with successful left atrial appendage closure
Secondary aims include successful LAA closure rates
Outcome measures
| Measure |
SentreHeart Lariat
n=9 Participants
Left atrial appendage closure with SentreHeart Lariat device
Left atrial appendage closure: 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®: 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.
|
|---|---|
|
Successful LAA Closure Rate
|
6 Participants
|
Adverse Events
SentreHeart Lariat
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SentreHeart Lariat
n=9 participants at risk
Left atrial appendage closure with SentreHeart Lariat device
Left atrial appendage closure: 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®: 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.
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
11.1%
1/9 • Number of events 1 • 180 days
Adverse events were collected as standard
|
|
Cardiac disorders
Positive nuclear stress test
|
11.1%
1/9 • Number of events 1 • 180 days
Adverse events were collected as standard
|
Other adverse events
| Measure |
SentreHeart Lariat
n=9 participants at risk
Left atrial appendage closure with SentreHeart Lariat device
Left atrial appendage closure: 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®: 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.
|
|---|---|
|
Cardiac disorders
hypotension
|
22.2%
2/9 • Number of events 2 • 180 days
Adverse events were collected as standard
|
|
Gastrointestinal disorders
diarrhea
|
11.1%
1/9 • Number of events 1 • 180 days
Adverse events were collected as standard
|
|
Renal and urinary disorders
UTI
|
11.1%
1/9 • Number of events 1 • 180 days
Adverse events were collected as standard
|
|
Cardiac disorders
pericardial effusion
|
11.1%
1/9 • Number of events 1 • 180 days
Adverse events were collected as standard
|
|
Cardiac disorders
unspecified chest pain
|
11.1%
1/9 • Number of events 1 • 180 days
Adverse events were collected as standard
|
|
Respiratory, thoracic and mediastinal disorders
bilateral pleural effusion
|
11.1%
1/9 • Number of events 1 • 180 days
Adverse events were collected as standard
|
Additional Information
Dr. J Brian DeVille
Baylor Scott and White The Heart Hospital Plano
Phone: 469-800-4540
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place