A Pilot Study Comparing the Programmed Delay Between the Atrial and Ventricle Interval (BRAVO-CRT)
A Pilot Study of theRelationship Between Atrio-Ventricular Delay and Changes in Biochemical Markers of Chronic Heart Failure During Cardiac Resynchronization Therapy (BRAVO-CRT)
The idea of this study is to compare different ways of setting up a pacemaker, using blood tests to give us information about how well it's working. We hope to learn if we can use this approach to figure out the best pacemaker setup ("programming") for each individual patient.
The setting we propose to adjust is the timing between the impulse sent between top and bottom chambers.
연구 개요
상세 설명
There are different kinds of pacemakers and different ways they can be set up to try to make the heart beat regularly. A normal heart has four chambers; these four chambers pump in a co-ordinated way to move blood effectively. When pacemakers were first invented, they told the heart when to pump, but didn't make the four chambers work well together. Newer pacemakers can give more detailed instructions, so the chambers work together more effectively. We already know that the newer (bi-ventricular) pacemakers work better for some patients with heart failure.
There are blood tests (often referred to as "markers") that give us information about how well your heart is working and about how your body is responding to heart failure. The idea of this study is to compare different ways of setting up a pacemaker, using these blood tests to give us information about how well it's working. We hope to learn if we can use this approach to figure out the best pacemaker setup ("programming") for each individual patient.
Usually pacemakers have two wires or leads, one is in the top right chamber and the other in the bottom right chamber of the heart. The newer pacemakers, which are given to patients with heart failure, have an additional lead or wire, which goes to the left side of the heart. So when heart contracts the lead from top chamber sends impulses to bottom chambers and the leads in right and left sides of bottom chamber responds by sending impulses in a co-ordinated way enabling heart to contract efficiently.
Currently, the standard way of treating patients with heart failure is by pacing the top and then bottom chambers, based on a timing interval determined by ultrasound, while also pacing the two bottom chambers in a coordinated manner. There are differences of opinion among experts and by previous studies regarding this method. Pacing is accomplished through pacemaker wires, which are placed in the right top chamber, the right bottom chamber and the left bottom chamber of the heart.
The setting we propose to adjust is the timing between the impulse sent between top and bottom chambers.
연구 유형
등록 (실제)
단계
- 초기 1단계
연락처 및 위치
연구 장소
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- University of Minnesota
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of chronic heart failure
- patients on stable pharmacologic therapy for at least 3 months
- EF< 35%
- age >18 years
- NYHA functional class III or IV
- eligible for either CRT pacer or CRT defibrillator for heart failure
- Ischemic or non-ischemic cardiomyopathy
- patients that are able to tolerate VDD mode with a lower rate of 40bpm programming
Exclusion Criteria:
- systolic blood pressure <70mmHg
- Likely to receive a left ventricular assist device or cardiac transplant within 6 months of implant procedure
- patients who have previously received a CRT device
- documented atrial fibrillation
- complete heart block
공부 계획
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: 1
AVD set by taking the larger of 0.50ms or A-V interval 0.30
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Comparision of A-V delay settings
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활성 비교기: 2
AVD set by taking the larger of 0.50ms or A-V interval 0.50
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Comparision of A-V delay settings
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활성 비교기: 3
AVD set by taking the larger of 0.50ms or A-V interval 0.70
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Comparision of A-V delay settings
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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To assess the effect of CRT atrioventricular delay settings on biochemical markers in blood through 6 months
기간: end of the study
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end of the study
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2차 결과 측정
결과 측정 |
기간 |
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assess effects of echocardiogram through 6months after CRT on heart failure
기간: end to study
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end to study
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assess the effects of minnesota Living with heart failure questionaire through 6 months after CRT on heart failure
기간: end of study
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end of study
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assess effects of six minute hall walk through 6 months after CRt on heart failure
기간: end of study
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end of study
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assess effects of SDANN through 6 months after CRT on heart failure
기간: end of study
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end of study
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공동 작업자 및 조사자
수사관
- 수석 연구원: David G Benditt, MD, University of Minnesota
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. .
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