Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at San Francisco, California and other locations
Dates
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 II/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

You can join if…

Open to people ages 18-99

  • Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
  • NYHA Class II/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

You CAN'T join if...

  • 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
  • Kaiser Permanente San Francisco accepting new patients
    San Francisco California 94118 United States

Details

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