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Active, not recruitingNCT03838445RELIEVE-PAHUpdated Jun 22, 2026

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

An interventional study of V-Wave Interatrial Shunt in Pulmonary Arterial Hypertension, sponsored by V-Wave Ltd. Active, not recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by V-Wave Ltd · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Pulmonary Arterial Hypertension

Keywords

  • Pulmonary Arterial Hypertension
  • PAH
  • Interatrial Shunt
  • Interatrial Shunting
  • Atrial Septostomy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main Inclusion Criteria:

  1. Group 1 PAH (idiopathic, connective tissue disease, HIV, corrected congenital heart disease).
  2. 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.
  3. Receiving maximal available and tolerable pharmacological PAH therapy ≥3 months at a stable dose for ≥1 month.

Main Exclusion Criteria:

  1. Resting oxygen saturation \<90 % without supplemental oxygen corrected for altitude.
  2. Mean Right Atrial Pressure >20 mmHg.
  3. Severe restrictive or obstructive lung disease.
  4. Evidence of organ dysfunction other than right heart failure.
  5. Left ventricular ejection fraction \<40 %.
  6. Anatomical anomaly on transesophageal echocardiography or intracardiac echocardiography that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum.
  7. Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent.
  8. Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Therapy: V-Wave Shunt

    Treatment arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation.

    Device: V-Wave Interatrial Shunt

Interventions

  • DeviceV-Wave Interatrial Shunt

    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.

05

What researchers measure

Primary outcomes

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

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

    Time frame: 3 months

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

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

    Time frame: 3 months

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

    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

    Time frame: 3 months

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

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

    Time frame: 3 months

Secondary outcomes

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

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

    Time frame: 1 and 12 months

  2. Improvement in Exercise Capacity between baseline and 12 months

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

    Time frame: 12 months

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

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

    Time frame: 12 months

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

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

    Time frame: 12 months

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

    Improvement in Quality of Life as measured by the CAMPHOR questionnaire

    Time frame: 12 months

06

Study locations

3 sites
  • Keck Medical Center of USC
    Los Angeles, California 90033, United States
  • University of California, San Francisco
    San Francisco, California 94143, United States
  • Instituto Nacional de Cardiologia
    Mexico City, Mexico
07

Registry details

Key details

Study ID
NCT03838445
Lead sponsor
V-Wave Ltd
Responsible party
Sponsor
First posted
Feb 12, 2019
Start date
Feb 14, 2020
Primary completion
Jun 30, 2026 (estimated)
Completion
May 2028 (estimated)
Last update
Jun 22, 2026

Study contacts

Victor Tapson, M.D.
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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