RELIEVE-PAH TRIAL: REducing Right ventricuLar faIlure With thE V-waVe Shunt in Pulmonary Arterial Hypertension
V-Wave Ltd
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 lun…
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.
Locations (5)
- Keck Medical Center of USCLos Angeles, California
- University of California, San FranciscoSan Francisco, California
- The Ohio State University Wexner Medical Center - Davis Heart & Lung Research InstituteColumbus, Ohio
- Institut universitaire de cardiologie et de pneumologie de Québec - Université LavalQuébec
- Instituto Nacional de CardiologiaMexico City