Left Atrial Appendage Occlusion Study II (LAAOSII)
Phase III Pilot Study - Left Atrial Appendage Occlusion Study
A pilot, multicentre randomized controlled study of surgical left atrial occlusion (LAA) in 50 patients with atrial fibrillation/flutter undergoing cardiac surgery requiring cardiopulmonary bypass with additional risk factors for late stroke.
Patients will be enrolled and randomized to undergo LAA exclusion and aspirin therapy or best medical therapy as per guidelines.
Main research questions:
- Can successful occlusion of the LAA be safely achieved by cut and sew or stapler techniques?
- In patients with atrial fibrillation with 2 or more risk factors for stroke, will removal of the left atrial appendage (LAA) and aspirin therapy reduce the risk of systemic embolic events and major bleeding compared to warfarin?
연구 개요
상태
상세 설명
The number one cause of disability and the 3rd leading cause of death in patients with atrial fibrillation (AF) is stroke. Echocardiographic studies suggest that the predominant source of stroke in AF is the left atrial appendage (LAA). At present, there are no sufficiently powered trials to answer whether removal of the LAA can reduce the risk of systemic embolic events.
LAAOS pilot study will recruit 50 participants undergoing open-heart surgery in 5 Canadian academic cardiac surgery centers. The study will inform the feasibility of conducting a large RCT and will provide information of the efficacy and safety of appendage occlusion technique. From this study we envision a a large international randomized controlled trial (LAAOS II) to determine the impact of left atrial appendage occlusion on the composite outcome of stroke and non-central nervous system systemic embolic events in at risk patients with atrial fibrillation undergoing cardiac surgery.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
Ontario
-
Hamilton, Ontario, 캐나다, L8L 2X2
- Hamilton General Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult patients undergoing any cardiac surgical procedure with the use of cardiopulmonary bypass
A history of ECG-documented atrial fibrillation with prior stroke or TIA, or at least two of the following risk factors:
- age => 65 years
- hypertension
- diabetes mellitus, or
- heart failure/left ventricular ejection fraction < 50%
Exclusion Criteria:
- Patients in whom surgical AF ablation (MAZE or otherwise) is planned
- Planned "off-pump" surgery
- Planned implantation of a mechanical valve
- Heart transplant, complex congenital heart surgery, and ventricular assist device insertion, reoperation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Occlusion arm
Surgical intervention: Occlusion of the left atrial appendage (LAA) using 'cut-and-sew' technique appendage occlusion.
|
Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device.
|
|
활성 비교기: Medical arm
Medical arm: The comparator is best medical practice for atrial fibrillation related stroke prevention as per guidelines.
|
Best medical practice for atrial fibrillation related stroke prevention as per guidelines.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Demonstration of efficacy of cut-and-sew and stapler technique of appendage occlusion by intraoperative transesophageal echocardiography, central adjudication.
기간: Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
|
Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Demonstration of study feasibility, procedure safety, including rate of post-operative re-exploration for bleeding.
기간: Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
|
Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Richard Whitlock, MD, FRCSC, McMaster University
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
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. .