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Active, Not Recruiting

NCT Number: NCT03499236

Reducing Lung CongestIon Symptoms in Advanced Heart Failure

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia

Loading trial locations.

About this study

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 500 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main 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

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 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

Treatment and study plan

V-Wave Interatrial Shunt

Device

The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovalis and straddles the interatrial septum.

Control

Other

Right heart catheterization, invasive echocardiography.

Primary outcomes

  1. Safety-Percentage of Treatment patients experiencing major device-related adverse events

    Time frame: 30-days after randomization

    Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 30-days after randomization, compared to a pre-specified Performance Goal

  2. Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device (LVAD) implantation, HF hospitalizations, worsening HF events treated as an outpatient, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months

    Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method

Secondary outcomes

  1. 6MWT changes

    Time frame: Baseline to 12 months

    6MWT changes

  2. KCCQ changes

    Time frame: Baseline to 12 months

    KCCQ changes

  3. KCCQ changes

    Time frame: Baseline through study completion, maximum of five years

    KCCQ changes

  4. Time to all-cause death, LVAD/Transplant, or heart failure hospitalization

    Time frame: Baseline through study completion, maximum of five years

    Time to all-cause death, LVAD/Transplant, or heart failure hospitalization

  5. Time to all-cause death or first heart failure hospitalization

    Time frame: Baseline through study completion, maximum of five years

    Time to all-cause death or first heart failure hospitalization

  6. Cumulative heart failure hospitalizations

    Time frame: Baseline through study completion, maximum of five years

    Cumulative heart failure hospitalizations

  7. Time to first heart failure hospitalization

    Time frame: Baseline through study completion, maximum of five years

    Time to first heart failure hospitalization

  8. Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ

    Time frame: Baseline through study completion, maximum of five years

    Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ

Sponsors and collaborators

Lead sponsor

V-Wave Ltd

Industry

Registry information

Official study title

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

Acronym: RELIEVE-HF

Important dates

Study start
2018
Primary completion
2023
Study completion
2027
First posted
Apr 17, 2018
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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