AMPLATZER Cardiac Plug Clinical Trial
Amplatzer Cardiac Plug Clinical Trial
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, 미국, 90017
- Good Samaritan Hospital
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Colorado
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Aurora, Colorado, 미국, 80045
- University of Colorado Denver
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Littleton, Colorado, 미국, 80120
- South Denver Cardiology Associates
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Georgia
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Atlanta, Georgia, 미국, 30308
- Emory Midtown Hospital and Emory University Hospital
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Atlanta, Georgia, 미국
- St. Joseph's Hospital and Research Institute
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Iowa
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Iowa City, Iowa, 미국, 52242
- University of Iowa Hospitals & Clinics
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Kentucky
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Lexington, Kentucky, 미국, 40506
- University of Kentucky
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Michigan
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Detroit, Michigan, 미국, 48202
- Henry Ford Hospital
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Grand Rapids, Michigan, 미국, 49503
- Spectrum Health
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Southfield, Michigan, 미국, 48075
- Providence Hospital
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Minnesota
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Saint Cloud, Minnesota, 미국, 56303
- St. Cloud Hospital/CentraCare Heart and Vascular Clinic
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Saint Paul, Minnesota, 미국, 55102
- HealthEast St. Joseph's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania
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York, Pennsylvania, 미국, 17405
- York Hospital
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South Carolina
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Charleston, South Carolina, 미국, 29401
- Roper Hospital/PMG Research of Charleston
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Texas
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Houston, Texas, 미국, 77030
- Memorial Hermann Hospital
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Wisconsin
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Wausau, Wisconsin, 미국, 54401
- Aspirus Heart & Vascular Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation
- Subject must be ≥18 years of age
- Subject must be on warfarin or dabigatran therapy
- Subject must be eligible for long term warfarin or dabigatran therapy
- Subject must have a CHADS(2) score of 2 or greater
Summary of Exclusion Criteria:
- Subject who requires warfarin or dabigatran for a condition other than AF
- Subject who is on clopidogrel or another P2Y12 platelet inhibitor such as prasugrel or ticagrelor
- Subject who has an absolute or relative contraindication to aspirin, or warfarin and dabigatran
- Subject with a New York Heart Association (NYHA) classification equal to IV
- Subject with an implanted or surgical repair atrial septal defect (ASD) device or patent foramen ovale (PFO) device
- Subject with aortic or mitral valve regurgitation of grade 2+ or greater
- Subject with left ventricular ejection fraction (LVEF) ≤30
- Subject with mitral or aortic prosthetic valve
- Subject with a history of hemorrhagic or aneurysmal stroke
- Subject with a history of previous radio frequency (RF) ablation for atrial fibrillation
- Subject with a body mass index (BMI) ≥40
- Subject with a history of acute or recent MI, or unstable angina, or coronary artery bypass graft surgery (within 6 months)
- Subject who is on aspirin dose therapy greater than 81mg/day at time of enrollment
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 |
|---|---|
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실험적: Device
AMPLATZER Cardiac Plug
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AMPLATZER Cardiac Plug is a percutaneous transcatheter device
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활성 비교기: Optimal Medical Therapy (control)
Warfarin Dabigatran
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AMPLATZER Cardiac Plug is a percutaneous transcatheter device
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only
기간: From Randomization to Discharge Visit
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An analysis comparing the rate of procedure related serious adverse events that occur in the device arm to a performance goal determined from literature reported rates for similar procedural techniques. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm below. The secondary endpoint analysis requirement was removed from the protocol. |
From Randomization to Discharge Visit
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Long-term Safety - Device Arm Only
기간: Randomization to 2 year follow-up
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All-Cause Mortality and Major Bleeds Through 2 years in device arm subjects only. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol. |
Randomization to 2 year follow-up
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Effectiveness Endpoint - Device Arm Only
기간: Randomization through 2 year follow up
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Occurrence of ischemic stroke and peripheral thromboembolism in the device arm. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol. |
Randomization through 2 year follow up
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공동 작업자 및 조사자
간행물 및 유용한 링크
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. .
AMPLATZER Cardiac Plug에 대한 임상 시험
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Medtronic Cardiac Rhythm and Heart Failure완전한
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Abbott Medical DevicesJapanese society of Congenital Interventional Cardiology모병
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Abbott Medical Devices모집하지 않고 적극적으로
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Abbott Medical Devices모병PFO - 오발 특허 구멍 | VSD - 근육 심실 중격 결손 | PIVSD - 경색 후 근육 심실 중격 결손 | ASD - 심방 중격 결손스페인, 독일, 폴란드, 프랑스, 이탈리아, 네덜란드, 스위스
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Abbott Medical Devices종료됨
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University Hospital Inselspital, Berne완전한