Actively Recruiting
Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)
Led by V-Wave Ltd · Updated on 2026-03-31
20
Participants Needed
5
Research Sites
619 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Group 1 pulmonary arterial hypertension (idiopathic, connective tissue disease, HIV, or corrected congenital heart disease)
- WHO Functional Class III or IV symptoms; if Class III, must have at least one high-risk or two intermediate-risk characteristics per 2015 ESC Guidelines
- Receiving maximal available and tolerable PAH drug therapy for at least 3 months at stable dose for at least 1 month
You will not qualify if you...
- Resting oxygen saturation less than 90% without supplemental oxygen corrected for altitude
- Mean right atrial pressure greater than 20 mmHg
- Severe restrictive or obstructive lung disease
- Organ dysfunction other than right heart failure
- Left ventricular ejection fraction less than 40%
- Anatomical abnormalities preventing implantation of shunt across interatrial septum
- Inadequate vascular access for shunt implantation such as blocked femoral venous access or inferior vena cava
- Hemodynamic, heart rhythm, or respiratory instability at final screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Keck Medical Center of USC
Los Angeles, California, United States, 90033
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute
Columbus, Ohio, United States, 43210
Withdrawn
4
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Canada
Withdrawn
5
Instituto Nacional de Cardiologia
Mexico City, Mexico
Active, Not Recruiting
Research Team
W
William T. Abraham, M.D.
CONTACT
B
Beverly Walker, MSN, NP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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