Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)

Description

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

Pulmonary Arterial Hypertension

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Study Overview

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Study Details

Study overview

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.

RELIEVE-PAH TRIAL: REducing Right ventricuLar faIlure With thE V-waVe Shunt in Pulmonary Arterial Hypertension

Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)

Condition
Pulmonary Arterial Hypertension
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Keck Medical Center of USC, Los Angeles, California, United States, 90033

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Columbus

The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

V-Wave Ltd,

Victor Tapson, M.D., PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

2026-12-31