NCT03838445Active, not recruiting
Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)
RELIEVE-PAH TRIAL: REducing Right ventricuLar faIlure With thE V-waVe Shunt in Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 6 Feb 2019
- Start date
- 14 Feb 2020
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- V-Wave Ltd
- NCT number
- NCT03838445
What you commit to
- Study type: Interventional
- Participants enrolled: 9
- From 14 Feb 2020 to the primary completion date, 30 Jun 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Nacional de Cardiologia Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Keck Medical Center of USC Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.