Left Atrial Appendage Closure With SentreHeart Lariat® Device (Lariat)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Texas
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Plano, Texas, 미국, 75093
- Baylor Research Institute at The Heart Hospital Baylor Plano
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: SentreHeart Lariat
Left atrial appendage closure with SentreHeart Lariat device
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants with Successful Stand-Alone Left Atrial Appendage Closure Using SentreHeart Lariat Device as Measured by Left Atrial Appendage Closure Rates
기간: 4 Years
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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
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4 Years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
기간: 4 Years
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Secondary aims include assessment of adverse events
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4 Years
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Successful LAA closure rate
기간: 4 years
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Secondary aims include successful LAA closure rates
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4 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: J. B. DeVille, MD, Prinicpal Investigator
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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