Reducing right ventricular failure in pulmonary arterial hypertension
RELIEVE-PAH TRIAL: REducing Right ventricuLar faIlure With thE V-waVe Shunt in Pulmonary Arterial Hypertension
This study is testing a new device to see if it can help people with severe pulmonary arterial hypertension feel better and reduce heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | V-Wave Ltd Industry-sponsored |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT03838445 on ClinicalTrials.gov |
What this trial studies
The RELIEVE-PAH study aims to gather first-in-human data on the safety and performance of the V-Wave Interatrial Shunt device in patients suffering from severe pulmonary arterial hypertension (PAH). This multi-national, multi-center, prospective trial will involve up to 20 patients who will be implanted with the device and monitored for one year, with follow-ups extending annually for up to five years. The study focuses on patients with WHO Functional Class III or IV symptoms who have been on stable PAH therapy for at least three months.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with Group 1 PAH who exhibit WHO Functional Class III or IV symptoms and have been on maximal pharmacological therapy.
Not a fit: Patients with severe lung disease, significant organ dysfunction, or those who cannot undergo the implantation procedure due to anatomical anomalies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option that may significantly improve outcomes for patients with severe pulmonary arterial hypertension.
How similar studies have performed: While this approach is novel, similar studies exploring interatrial shunting in heart failure have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California and 4 other locations
- Keck Medical Center of USC — Los Angeles, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute — Columbus, Ohio, United States (Withdrawn)
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec, Canada (Withdrawn)
- Instituto Nacional de Cardiologia — Mexico City, Mexico (Active_not_recruiting)
Study contacts
- Principal investigator: Victor Tapson, M.D. — Cedars-Sinai Medical Center
- Study coordinator: William T. Abraham, M.D.
- Email: bill@vwavemedical.com
- Phone: (818)629-2164
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.