Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03838445

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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Withdrawn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

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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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