Heart Failure
Conditions
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.
Interventions
DEVICEV-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.
OTHERControl
Right heart catheterization, invasive echocardiography.
Sponsors
V-Wave Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
In the randomized cohort, participants, the clinical team, and research staff managing the patient after randomization will be blinded to study assignment.
Intervention model description
Randomized treatment versus control (1:1). Control patients will be allowed to cross-over at the completion of the blinded phase. A parallel roll-in arm will enroll up to 2 patients per site in an open-label study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
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 Main
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Cumulative heart failure hospitalizations | Baseline through study completion, maximum of five years | Cumulative heart failure hospitalizations |
| KCCQ changes | Baseline to 12 months | KCCQ changes |
Countries
Australia, Belgium, Canada, Germany, Israel, Netherlands, New Zealand, Poland, Spain, Switzerland, United States
Outcome results
None listed