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 (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
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.
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.
699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.
This study's enrollment of 9 is below the median of 40 across 477 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →V-Wave Ltd is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
First submitted before V-Wave Ltd became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
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
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
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
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
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
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
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
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
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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Pulmonary Arterial Hypertension →