증상이 있는 심부전의 동기화된 횡격막 자극 (RECOVER-HF)
RECOVER-HF - 증상이 있는 박출률 감소 심부전 개선을 위한 동기식 횡격막 자극(SDS)에 대한 무작위, 다기관, 이중 맹검 연구
RECOVER HF is a clinical study designed to evaluate the safety and efficacy of Synchronized Diaphragmatic Stimulation delivered using the VisONE System in the treatment of patients with heart failure.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Symptomatic Diaphragmatic Stimulation (SDS) is a novel extra-cardiac device for patients who have symptomatic heart failure. Elevated intracardiac pressures are the hallmark of heart failure (HF) and a key pathological driver of disease progression and limited exertional capacity. The degree of cardiac pressure elevation is determined by preload, afterload, and pericardial restraint. The pericardium restrains the heart, and the degree of restraint is determined by the pericardial structure itself and the intrathoracic pressure. This aspect of HF pathophysiology is among the fundamental drivers behind the SDS therapy concept. SDS induces a temporal modulation of intrathoracic pressure.. When synchronized with the cardiac cycle, SDS may improve cardiac filling, cardiovascular pressure conditions, and cardiac performance
RECOVER HF is a prospective, randomized, doubled-blinded study of Synchronized Diaphragmatic Stimulation (SDS) delivered in an imperceptible manner in subjects with heart failure defined as New York Heart Association (NYHA) functional class II/III, left-ventricular ejection fraction (LVEF) <=40%, and QRS duration <=130ms despite receiving the appropriate heart failure guideline directed medical therapy (GDMT). All subjects will receive an implanted VisONE System. Two-weeks post implant subjects will be randomized in a 1:1 ratio into a SDS therapy active or control (SDS therapy inactive) arm with both arms receiving GDMT. At 6 months the control arm will have SDS therapy activated with all patients receiving therapy and GDMT throughout the remainder of the study period. The study will be conducted at up to 30 investigational sites in the United States and several outside the U.S. These centers will enroll subjects with the goal of randomizing approximately 270 subjects who meet the entry criteria.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Calvin Flowers
- 전화번호: (503) 431-3823
- 이메일: flowersc@viscardia.com
연구 연락처 백업
- 이름: Joelle Duker
- 전화번호: (503) 431-3800
- 이메일: dukerj@viscardia.com
연구 장소
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Tbilisi, 그루지야, 0159
- 모병
- Tbilisi Heart and Vascular Clinic
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수석 연구원:
- Tamaz Shaburishvili, MD
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연락하다:
- Tamaz Shaburishvili, MD
- 전화번호: 0322 157 159
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Indiana
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Indianapolis, Indiana, 미국, 46260
- 모병
- Ascension St. Vincent Hospital
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연락하다:
- Sangita Sudharshan
- 전화번호: (317) 338-6666
- 이메일: sangita.sudharshan@ascension.org
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수석 연구원:
- Sangita Sudharshan, MD
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Oklahoma
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Tulsa, Oklahoma, 미국, 74136
- 모병
- Saint Francis Hospital
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수석 연구원:
- Ralph D Ensley, MD
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연락하다:
- Ralph D Ensley, MD
- 전화번호: (918) 494-8500
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- 모병
- University of Pennsylvania
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수석 연구원:
- Aditya Parikh, MD
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연락하다:
- Aditya Parikh, MD
- 전화번호: (215) 615-4949
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Texas
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Houston, Texas, 미국, 77030
- 모병
- Baylor College of Medicine
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수석 연구원:
- Ajith Nair, MD
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연락하다:
- Ajith Nair, MD
- 전화번호: (713) 798-6230
- 이메일: ajith.nair@bcm.edu
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT) for 3 months
- EF≤ 40%
- At the time of consent, willing and able to comply with protocol requirements, including attending all required visits
- Willing to participate in the study and able to sign an informed consent form
- ≥18 years of age at the time of consent
Exclusion Criteria:
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Baseline 6-minute walk test > 500 meters or < 200 meters
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NT-proBNP< 250 if on loop diuretics, or NT-proBNP < 500 if not on loop diuretics
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Supine resting heart rate > 140 bpm
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Systolic blood pressure < 80 mmHg or > 170 mmHg
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Serum creatinine > 2.5 mg/dL
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Serum hepatic function 3x ULN
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Any of the following within the previous 3 months: unstable angina, AMI, CABG, PTCA, CVA/TIA, AF (episodes > 24 hours), symptomatic NSVT or DCCV
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Any inotropic drug treatment within the previous 3 months
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Bradycardia (heart rate < 50 beats/min), atrial arrhythmias with rates > 100 beats/min, sustained ventricular tachycardia or frequent ventricular ectopy >10% present during screening
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Significant uncontrolled symptomatic bradyarrhythmia, atrial fibrillation, unstable ventricular arrhythmias or frequent ventricular ectopy > 10% documented within the previous 3 months
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Reversible non-ischemic cardiomyopathy
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Valvular disease requiring intervention within the next 12 months or presence of significant valve disease as determined by the site cardiologist as:
- Greater than mild mitral valve stenosis
- Greater than moderate mitral valve regurgitation
- Greater than mild tricuspid valve stenosis
- Greater than moderate-severe tricuspid valve regurgitation
- Greater than moderate aortic stenosis
- Greater than moderate aortic regurgitation
- Greater than mild-moderate pulmonic stenosis
- Greater than moderate pulmonic regurgitation
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Severe primary pulmonary disease, including pulmonary arterial hypertension. PAP sys >70 mmHg at rest
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Severe COPD, other respiratory or lung diseases where FEV1 < 50%
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Presence of more than small pleural effusion or history of pleural drainage within the previous 6 months
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Known history of diaphragmatic paralysis or suspicion confirmed by unilateral or bilateral elevation of the diaphragm on chest x-ray
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Pericardial disease
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Non-cardiac condition substantially impairing ambulation of 6-minute hall walk test interpretation
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Existing diaphragmatic stimulation for respiration assist
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Present LVAD, Baroreflex Activation Therapy, Cardiac Contractility Modulation or interatrial shunt devices; temporary mechanical cardiac assist devices (current or within the previous 3 months)
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Contraindications to laparoscopic access to the diaphragm, as determined by the implanting physician
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Known intra-abdominal pathology which could increase the risk of laparoscopic access to the diaphragm.
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Previous open laparotomy within 1 year
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Previous thoracic or abdominal organ transplant
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Drug induced immuno-suppression
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Body mass index > 40
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Enrollment in a concurrent investigation / clinical study
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Having a life expectancy of <1 year due to any condition
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Pregnant or planning a pregnancy during the study period
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Known allergies to implantable device materials
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History of systemic infection requiring the use of intravenous antibiotics within the previous 3 months
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Received cardiac resynchronization therapy (CRT) within six months of randomization, or is actively receiving CRT
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Currently have a Class I indication for a cardiac resynchronization therapy (CRT) device according to AHA/ACC/ESC guidelines for the treatment of congestive heart failure
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Device and Medical Management
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Implantable Pulse Generator system providing cardiac-gaited stimulation of the diaphragm and thereby influence cardiovascular properties relevant in heart failure.
다른 이름들:
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가짜 비교기: Medical Management
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Implantable Pulse Generator system providing cardiac-gaited stimulation of the diaphragm and thereby influence cardiovascular properties relevant in heart failure.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Left ventricular End-Systolic Volume (LVESV)
기간: 6 months
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To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger percent improvement in LVESV at 6 months post-randomization from baseline than medical management alone. |
6 months
|
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Six Minute Hall Walk (6MHW)
기간: 6 months
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To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in 6MHW at 6 months post-randomization from baseline than medical management alone. |
6 months
|
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Minnesota Living with Heart Failure quality of Life Score (MLWHF QOL)
기간: 6 months
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To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in MLWHF QOL at 6 months post-randomization from baseline than medical management alone. |
6 months
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Major Adverse Respiratory and Cardiovascular Events (MARCE)
기간: 6 months
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To demonstrate the safety of the VisONE System by analyzing Major Adverse Respiratory and Cardiovascular Events (MARCE) occurring within 6 months post implant for the rate, severity and association with the device or procedure (goal >70% freedom):
|
6 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Left Ventricular Ejection Fraction (LVEF)
기간: 6 months
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To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in LVEF at 6 months post-randomization from baseline than medical management alone. |
6 months
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N-Terminal Pro Brain Natriuretic Peptide (NT-proBNP)
기간: 6 months
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To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger reduction in NT-proBNP (log-10 transformed) at 6 months post-randomization from baseline than medical management alone. |
6 months
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Left ventricular End-Systolic Volume (LVESV)
기간: 12 months
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To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger percent improvement in LVESV at 12 months post-randomization from baseline than medical management alone. |
12 months
|
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Six Minute Hall Walk (6MHW)
기간: 12 months
|
To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in 6MHW at 12 months post-randomization from baseline than medical management alone. |
12 months
|
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Minnesota Living with Heart Failure quality of Life Score (MLWHF QOL)
기간: 12 months
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To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in MLWHF QOL at 12 months post-randomization from baseline than medical management alone. |
12 months
|
|
Left Ventricular Ejection Fraction (LVEF)
기간: 12 months
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To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in LVEF at 12 months post-randomization from baseline than medical management alone. |
12 months
|
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N-Terminal Pro Brain Natriuretic Peptide (NT-proBNP)
기간: 12 months
|
To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger reduction in NT-proBNP (log-10 transformed) at 12 months post-randomization from baseline than medical management alone. |
12 months
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Lee R Goldberg, MD, University of Pennsylvania
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- VisCardia H03_22
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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