Reducing Lung CongestIon Symptoms in Advanced Heart Failure

Trial ID or NCT#

NCT03499236

Status

recruiting iconRECRUITING

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 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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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 Main
Exclusion Criteria:
  1. - 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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Investigator(s)

Christiane Haeffele
Christiane Haeffele
Cardiologist, Adult congenital heart disease cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology

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Contact

Jeffrey Teuteberg, MD

View on ClinicalTrials.gov