Summary

for people ages 18-99 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

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 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.

Official Title

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

Details

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.

Keywords

Heart Failure V-Wave Interatrial Shunt Roll in

Eligibility

For people ages 18-99

Main 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

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 m2

  • 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

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Central Cardiology Medical Center accepting new patients
    Bakersfield California 93308 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
V-Wave Ltd
ID
NCT03499236
Study Type
Interventional
Last Updated