RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 605
- 试验地点
- 166
- 主要终点
- Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device (LVAD) implantation, HF hospitalizations, worsening HF events treated as an outpatient, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
研究概览
简要总结
The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional Class II, Class III, or ambulatory Class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.
详细描述
This is a prospective, multi-center, 1:1 randomized, patient and observer blinded clinical study, with a Shunt Treatment arm and a non-implant Control arm. A total of approximately 500 patients will be randomized. Patients and all research staff managing the patients after randomization will be blinded during follow-up for a minimum of 12 months to a maximum of 24 months. Control patients will have the opportunity to receive a shunt after 24 months once unblinding occurs, if they provide consent, and continue to meet inclusion/exclusion criteria. All implanted patients will be followed for a total of 5 years from the time of the study device implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In the randomized cohort, participants, the clinical team, and research staff managing the patient after randomization will be blinded to study assignment.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
- •NYHA Class II, Class III, or ambulatory Class IV HF
- •Receiving guideline directed medical and device therapy (GDMT) for heart failure
- •For NYHA Class III and ambulatory Class IV, at least one prior hospitalization for heart failure within the last year or elevated BNP level of at least 300 pg/ml or NT-proBNP level of at least 1,500 pg/ml. BNP/NT-ProBNP levels corrected for BMI
- •For NYHA Class II, must have both hospitalization and elevated BNP levels as above specifications
排除标准
- •Systolic blood pressure <90 or >160 mmHg
- •Presence of Intracardiac thrombus
- •Pulmonary hypertension with PASP of ≥70 mm/Hg or PVR > 4 WU
- •Significant RV dysfunction - TAPSE <12mm or RVFAC ≤25%
- •Left Ventricular End-Diastolic Diameter (LVEDD) >8cm
- •Moderate to severe aortic or mitral stenosis
- •Stroke or TIA or DVT within the last 6 months
- •eGFR <25 ml/min/1.73 m^2
- •Anatomical anomaly on TEE or ICE that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum
- •Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent
- •Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria
研究组 & 干预措施
Treatment
Treatment arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation
干预措施: V-Wave Interatrial Shunt (Device)
Control
Control arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility, but will not have transseptal catheterization or shunt implantation.
干预措施: Control (Other)
Roll in
Roll in arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation
干预措施: V-Wave Interatrial Shunt (Device)
结局指标
主要结局
Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device (LVAD) implantation, HF hospitalizations, worsening HF events treated as an outpatient, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
时间窗: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method
Safety-Percentage of Treatment patients experiencing major device-related adverse events
时间窗: 30-days after randomization
Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 30-days after randomization, compared to a pre-specified Performance Goal
次要结局
- Time to all-cause death, LVAD/Transplant, or heart failure hospitalization(Baseline through study completion, maximum of five years)
- Time to first heart failure hospitalization(Baseline through study completion, maximum of five years)
- 6MWT changes(Baseline to 12 months)
- KCCQ changes(Baseline through study completion, maximum of five years)
- Cumulative heart failure hospitalizations(Baseline through study completion, maximum of five years)
- Time to all-cause death or first heart failure hospitalization(Baseline through study completion, maximum of five years)
- Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ(Baseline through study completion, maximum of five years)
- KCCQ changes(Baseline to 12 months)