Official Title

RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure

Purpose

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 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 400 patients will be randomized. Patients 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 once unblinded, 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.

Eligibility Criteria

Inclusion Criteria

Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients

NYHA Class III or ambulatory Class IV HF

Receiving guideline directed medical therapy (GDMT) for heart failure

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

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 Exclusion Criteria

Keywords and/or Specific Medical Conditions

Heart Failure

Cardiovascular Diseases

CL7018

Heart Diseases

Internal Medicine

Otorhinolaryngology

Sponsors

V-Wave Ltd