Atrial Fibrillation Clinical Trial
— LariatOfficial title:
Left Atrial Appendage Closure With SentreHeart Lariat® Device
NCT number | NCT02681042 |
Other study ID # | 014-292 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | May 2, 2018 |
Verified date | January 2018 |
Source | Baylor Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | May 2, 2018 |
Est. primary completion date | May 2, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Baylor Research Institute at The Heart Hospital Baylor Plano | Plano | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 4 Years | |
Secondary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Secondary aims include assessment of adverse events | 4 Years | |
Secondary | Successful LAA closure rate | Secondary aims include successful LAA closure rates | 4 years |
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