Reducing Lung CongestIon Symptoms in Advanced Heart Failure

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    500
  • sponsor
    V-Wave Ltd
Updated on 21 August 2021
medical therapy
ejection fraction
heart failure
pulmonary congestion
nt-probnp
congestion
b-type natriuretic peptide
heart failure with preserved ejection fraction

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.

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 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.

Details
Condition Heart failure, Heart disease, Congestive Heart Failure, Cardiac Disease, cardiac failure, congestive heart disease
Treatment Control, V-Wave Interatrial Shunt
Clinical Study IdentifierNCT03499236
SponsorV-Wave Ltd
Last Modified on21 August 2021

Eligibility

Yes No Not Sure

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

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
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