Reducing Lung CongestIon Symptoms in Advanced Heart Failure
- Conditions
- Heart Failure
- Registration Number
- NCT03499236
- Lead Sponsor
- V-Wave Ltd
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 605
- 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
Main
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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) 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 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
- Secondary Outcome Measures
Name Time Method KCCQ changes Baseline through study completion, maximum of five years KCCQ changes
Time to first heart failure hospitalization Baseline through study completion, maximum of five years Time to first heart failure hospitalization
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 Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ
Time to all-cause death, LVAD/Transplant, or heart failure hospitalization Baseline through study completion, maximum of five years Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
Cumulative heart failure hospitalizations Baseline through study completion, maximum of five years Cumulative heart failure hospitalizations
Time to all-cause death or first heart failure hospitalization Baseline through study completion, maximum of five years Time to all-cause death or first heart failure hospitalization
6MWT changes Baseline to 12 months 6MWT changes
Trial Locations
- Locations (83)
Abrazo Arizona Heart Hospital
🇺🇸Phoenix, Arizona, United States
Arizona Heart Rhythm Center
🇺🇸Phoenix, Arizona, United States
Scripps Health
🇺🇸La Jolla, California, United States
Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States
Keck Medical Center of USC
🇺🇸Los Angeles, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Kaiser Permanente San Francisco
🇺🇸San Francisco, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Stanford Hospital
🇺🇸Stanford, California, United States
Los Robles Hospital & Medical Center
🇺🇸Thousand Oaks, California, United States
Scroll for more (73 remaining)Abrazo Arizona Heart Hospital🇺🇸Phoenix, Arizona, United States