An interventional study of V-Wave Interatrial Shunt and Control in Heart Failure, sponsored by V-Wave Ltd. Active, not recruiting at 83 sites in 11 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by V-Wave Ltd · Not applicable, Interventional, and Treatment
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.
Main Inclusion Criteria:
Main Exclusion Criteria:
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
Device: V-Wave Interatrial Shunt
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.
Other: Control
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
Device: V-Wave Interatrial Shunt
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
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
Plan to share: Yes
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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V-Wave Ltd