- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00146848
PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy (PEGASUS CRT)
2011년 12월 20일 업데이트: Boston Scientific Corporation
Pacing Evaluation - Atrial Support Study in Cardiac Resynchronization Therapy
This study will look at different pacing modes (how a device is programmed to pace one's heart), and how these modes may assist in one's daily activities and how one is feeling.
연구 개요
상태
완전한
정황
상세 설명
PEGASUS CRT is a multicenter trial that will assess the effect of a cardiac resynchronization therapy defibrillator (CRT-D) device programmed to DDD-70 or DDDR-40 compared to a CRT device programmed to DDD-40 in heart failure patients.
The effect of atrial support pacing in heart failure patients will be assessed using a clinical composite rating.
A sub-study will evaluate the effect pacing mode has on exercise capacity in this heart failure population.
연구 유형
중재적
등록 (실제)
1742
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ohio
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Cleveland, Ohio, 미국, 44195
- The Cleveland Clinic Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Patients who meet current indications for the CONTAK RENEWAL® family of cardiac resynchronization therapy defibrillator (CRT-D) devices or future Food and Drug Administration (FDA) approved Guidant CRT-D devices
- Patients who sign and date a Patient Informed Consent at, or prior to, the implant visit
- Patients who are in sinus rhythm at the time of implant
- Patients who remain in the clinical care of the enrolling physician in approved centers
- Patients who are on optimal pharmacologic therapy or who have developed a recent implantable cardioverter defibrillator (ICD) indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy
Exclusion Criteria:
- Patients whose medical condition is expected to preclude the use of the protocol-required pacing mode (dual chamber pacing [DDD or DDDR]) and respective lower rate limits
- Patients with permanent atrial fibrillation or atrial flutter
- Patients who are in complete heart block
- Patients who have previously had a pacemaker, ICD, or CRT device
- Patients whose life expectancy is less than 12 months due to other medical conditions
- Patients who are expected to receive a heart transplant during the duration of the study
- Patients who have other cardiac surgeries or procedures planned but not yet performed
- Patients who currently have or who are likely to receive a tricuspid valve prosthesis
- Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study.
- Patients who are younger than 18 years of age
- Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
- Patients who are or become pregnant
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: DDD-40
DDD-40 for this trial is the comparator arm.
Even though patients are receiving a CRT-D device, atrial support pacing in this arm will be limited as the device will not pace unless the rate falls below 40 bpm.
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All subjects in this trial receive the same device.
For the purpose of this trial, "intervention" is programming mode and lower rate limit to deliver atrial support pacing in the two treatment arms, while the control arm will receive programming where limited atrial support pacing is delivered.
DDD-70 and DDDR-40 are the treatment arms programmed to receive atrial support pacing and will be compared to the DDD-40 arm.
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활성 비교기: DDDR-40
DDDR-40 programming will initiate atrial support pacing if the rate falls below 40 bpm or if atrial support is needed in response to increased activity.
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All subjects in this trial receive the same device.
For the purpose of this trial, "intervention" is programming mode and lower rate limit to deliver atrial support pacing in the two treatment arms, while the control arm will receive programming where limited atrial support pacing is delivered.
DDD-70 and DDDR-40 are the treatment arms programmed to receive atrial support pacing and will be compared to the DDD-40 arm.
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활성 비교기: DDD-70
Atrial support pacing in this arm will be delivered when the rate falls below 70 bpm.
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All subjects in this trial receive the same device.
For the purpose of this trial, "intervention" is programming mode and lower rate limit to deliver atrial support pacing in the two treatment arms, while the control arm will receive programming where limited atrial support pacing is delivered.
DDD-70 and DDDR-40 are the treatment arms programmed to receive atrial support pacing and will be compared to the DDD-40 arm.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Clinical Composite Score
기간: From randomization (6-weeks) through 12-month visit
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The primary outcome measure classified patients as improved, unchanged or worsened, based on a 4 components clinical composite score using the following four components: death, heart failure hospitalization, New York Heart Association [NYHA] class, patient's Global Assessment rating.
Best value is improved, whereas worst value is worsened.
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From randomization (6-weeks) through 12-month visit
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Quality of Life
기간: From randomization (6-weeks) through 12-month visit
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Quality of Life as assessed by the Minnesota Living with Heart Failure Questionniare for those patients with paired data at 6 weeks and 12 months.
This score is on a scale of 0(best)- 105(worst).
A negative change denotes improvement.
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From randomization (6-weeks) through 12-month visit
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Change in Self Assessed Physical Activity
기간: From randomization (6-weeks) through 12-month visit
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Physical activity was assessed using the Physical Activity Scale of the Elderly (PASE) questionnaire for those patients with paired data available at the 6 week and 12 month visits.
The PASE is designed to assess physical activity in older persons.
The total PASE score was computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by empirically derived item weights and summing over all activities.
PASE scores for this study ranged from 0 to 756 with higher scores indicating more physical activity.
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From randomization (6-weeks) through 12-month visit
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: David O. Martin, MD, MPH, The Cleveland Clinic
- 수석 연구원: John Day, Utah Heart Clinic, LDS Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Martin DO, Stolen KQ, Brown S, Yu Y, Christie C, Doshi SK, Smith JM, Gold MR, Day JD. Pacing Evaluation-Atrial SUpport Study in Cardiac Resynchronization Therapy (PEGASUS CRT): design and rationale. Am Heart J. 2007 Jan;153(1):7-13. doi: 10.1016/j.ahj.2006.10.013.
- Martin DO, Day JD, Lai PY, Murphy AL, Nayak HM, Villareal RP, Weiner S, Kraus SM, Stolen KQ, Gold MR. Atrial support pacing in heart failure: results from the multicenter PEGASUS CRT trial. J Cardiovasc Electrophysiol. 2012 Dec;23(12):1317-25. doi: 10.1111/j.1540-8167.2012.02402.x. Epub 2012 Jul 25.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2004년 12월 1일
기본 완료 (실제)
2009년 1월 1일
연구 완료 (실제)
2009년 2월 1일
연구 등록 날짜
최초 제출
2005년 9월 2일
QC 기준을 충족하는 최초 제출
2005년 9월 6일
처음 게시됨 (추정)
2005년 9월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2011년 12월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2011년 12월 20일
마지막으로 확인됨
2011년 12월 1일
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. .