Reducing Lung CongestIon Symptoms in Advanced Heart Failure

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Main Inclusion Criteria:


  1. Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
  2. NYHA Class II, Class III, or ambulatory Class IV HF
  3. Receiving guideline directed medical and device therapy (GDMT) for heart failure
  4. 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
  5. For NYHA Class II, must have both hospitalization and elevated BNP levels as above specifications

EXCLUSION CRITERIA

Main Exclusion Criteria:


  1. Systolic blood pressure <90 or >160 mmHg
  2. Presence of Intracardiac thrombus
  3. Pulmonary hypertension with PASP of ≥70 mm/Hg or PVR > 4 WU
  4. Significant RV dysfunction - TAPSE <12mm or RVFAC ≤25%
  5. Left Ventricular End-Diastolic Diameter (LVEDD) >8cm
  6. Moderate to severe aortic or mitral stenosis
  7. Stroke or TIA or DVT within the last 6 months
  8. eGFR <25 ml/min/1.73 m^2
  9. Anatomical anomaly on TEE or ICE that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum
  10. Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent
  11. * Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition
Heart Failure
Age (in years)
18 - 99
Phase
NA
Participants needed
605
Est. Completion Date
Oct 31, 2027
Treatment type
INTERVENTIONAL

Sponsor
V-Wave Ltd
ClinicalTrials.gov identifier
NCT03499236
Study number
CL7018

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