Left Atrial Appendage Closure With SentreHeart Lariat® Device
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/20/2018 |
| Start Date: | March 2015 |
| End Date: | March 2019 |
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.
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.
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.
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
We found this trial at
1
site
Plano, Texas 75093
Principal Investigator: J. B. DeVille, MD
Phone: 469-814-4735
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