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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
605
The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovalis and straddles the interatrial septum.
Right heart catheterization, invasive echocardiography.
Safety-Percentage of Treatment patients experiencing major device-related adverse events
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
Time frame: 30-days after randomization
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)
Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method
Time frame: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
6MWT changes
6MWT changes
Time frame: Baseline to 12 months
KCCQ changes
KCCQ changes
Time frame: Baseline to 12 months
KCCQ changes
KCCQ changes
Time frame: Baseline through study completion, maximum of five years
Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
Time frame: Baseline through study completion, maximum of five years
Time to all-cause death or first heart failure hospitalization
Time to all-cause death or first heart failure hospitalization
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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
...and 73 more locations
Time frame: Baseline through study completion, maximum of five years
Cumulative heart failure hospitalizations
Cumulative heart failure hospitalizations
Time frame: Baseline through study completion, maximum of five years
Time to first heart failure hospitalization
Time to first heart failure hospitalization
Time frame: 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
Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ
Time frame: Baseline through study completion, maximum of five years