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NCT Number: NCT03838445

Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)

The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible signals of clinical effectiveness.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Cardiologia, Mexico City, Mexico

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About this study

This is a multi-national, multi-center, prospective, non-randomized, open label trial of patients implanted with the study device. A total of up to 20 patients will be implanted with the study device and followed at regular intervals for 1 year and then annually for a total of 5 years post implant.

Who can participate

Healthy volunteers accepted: No

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

Main Inclusion Criteria:

  • Group 1 PAH (idiopathic, connective tissue disease, HIV, corrected congenital heart disease).
  • WHO Functional Class III or IV symptoms. If WHO Class III, at least 1 High-Risk characteristic or 2 Intermediate-Risk characteristics from the 2015 ESC Guidelines.
  • Receiving maximal available and tolerable pharmacological PAH therapy ≥3 months at a stable dose for ≥1 month.

Main Exclusion Criteria:

  • Resting oxygen saturation <90 % without supplemental oxygen corrected for altitude.
  • Mean Right Atrial Pressure >20 mmHg.
  • Severe restrictive or obstructive lung disease.
  • Evidence of organ dysfunction other than right heart failure.
  • Left ventricular ejection fraction <40 %.
  • Anatomical anomaly on transesophageal echocardiography or intracardiac echocardiography 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 ovals and straddles the interatrial septum.

Primary outcomes

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

    Time frame: 3 months

    Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation

  2. Safety-Percentage of Treatment patients experiencing any major adverse event

    Time frame: 3 months

    Percentage of Treatment group patients experiencing any Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation

  3. Procedure Success-Percentage of patients successfully implanted with study device

    Time frame: 3 months

    Percentage of patients successfully implanted with the study device at the intended location across the interatrial septum during the index procedure compared to patients with attempted implantations

  4. Device Success-Percentage of patients implanted with right to left interatrial flow

    Time frame: 3 months

    Percentage of patients successfully implanted with the study device with right to left interatrial flow on echocardiography at 3 months

Secondary outcomes

  1. Freedom from device related MACNE at 1 and 12 months after implantation

    Time frame: 1 and 12 months

    Freedom from device related Major Adverse Cardiac and Neurologic Events at 1 and 12 months after implantation.

  2. Improvement in Exercise Capacity between baseline and 12 months

    Time frame: 12 months

    Improvement in Exercise Capacity measured by the six minute hall walk test from baseline to 12 months

  3. Improvement in WHO Functional Class between baseline and 12 months

    Time frame: 12 months

    Improvement in World Health Organization Functional Class between baseline and 12 months.

  4. Improvement in Quality of Life between baseline and 12 months

    Time frame: 12 months

    Improvement in Quality of Life as measured by the SF-36 questionnaire

  5. Improvement in Quality of Life between baseline and 12 months

    Time frame: 12 months

    Improvement in Quality of Life as measured by the CAMPHOR questionnaire

Sponsors and collaborators

Lead sponsor

V-Wave Ltd

Industry

Registry information

Official study title

RELIEVE-PAH TRIAL: REducing Right ventricuLar faIlure With thE V-waVe Shunt in Pulmonary Arterial Hypertension

Acronym: RELIEVE-PAH

Important dates

Study start
2020
Primary completion
2026
Study completion
2028
First posted
Feb 12, 2019
Registry last updated
Jun 22, 2026

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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