RELIEVE-PAH TRIAL: REducing Right ventricuLar faIlure With thE V-waVe Shunt in Pulmonary Arterial Hypertension
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Keck Medical Center of USC
RECRUITING
Los Angeles
University of California, San Francisco
RECRUITING
San Francisco
Ohio
The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute
WITHDRAWN
Columbus
Other Locations
Canada
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
WITHDRAWN
Québec
Mexico
Instituto Nacional de Cardiologia
ACTIVE_NOT_RECRUITING
Mexico City
Contact Information
Primary
William T. Abraham, M.D.
bill@vwavemedical.com
(818)629-2164
Backup
Beverly Walker, MSN, NP
beverly@vwavemedical.com
(818)629-2164
Time Frame
Start Date: 2020-02-14
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Therapy: V-Wave Shunt
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: V-Wave Ltd