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Pulmonary Arterial HypertensionRELIEVE-PAHNCT03838445

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

A study testing V-Wave Interatrial Shunt in people with Pulmonary Arterial Hypertension, run by V-Wave Ltd at 3 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
V-Wave Interatrial Shunt
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
3 sitesin 2 countries
Study dates
14 Feb 2020to May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Keck Medical Center of USC

    Los Angeles, California, 90033

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

Mexico1 site

  • Instituto Nacional de Cardiologia

    Mexico City

Other trials in Mexico

About this study

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

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.

Being tested
V-Wave Interatrial Shunt
Keywords
Pulmonary Arterial Hypertension, PAH, Interatrial Shunt, Interatrial Shunting, Atrial Septostomy
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • V-Wave Interatrial ShuntDevice

    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.

Study groups in NCT03838445
Study groupRoleWhat they receive
Therapy: V-Wave ShuntExperimentalTreatment 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.
Receives: Device: V-Wave Interatrial Shunt

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 3 months

Secondary outcomes (5)

  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.

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 12 months

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

    Improvement in Quality of Life as measured by the CAMPHOR questionnaire

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2019
  2. Study start14 Feb 2020
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03838445
Sponsor's protocol ID
CL7012
Acronym
RELIEVE-PAH
Status last verified
Jun 2026
First submitted
6 Feb 2019
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing V-Wave Interatrial Shunt in people with Pulmonary Arterial Hypertension, run by V-Wave Ltd at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety-Percentage of Treatment patients experiencing major device-related adverse events (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03838445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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