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

a study on High Blood Pressure Pulmonary Arterial Hypertension Pulmonary Hypertension

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Marc Simon, MD
Headshot of Marc Simon
Marc Simon

Description

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.

Official Title

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

Details

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.

Keywords

Pulmonary Arterial Hypertension PAH Interatrial Shunt Interatrial Shunting Atrial Septostomy Familial Primary Pulmonary Hypertension Hypertension V-Wave Interatrial Shunt Therapy: V-Wave Shunt

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Keck Medical Center of USC accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at UCSF

  • Marc Simon, MD
    Dr. Simon is director of Pulmonary Vascular Disease and the Pulmonary Hypertension Comprehensive Care Center. He has expertise as a cardiologist specializing in pulmonary hypertension, advanced heart failure, and heart transplantation.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
V-Wave Ltd
ID
NCT03838445
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated
Contact us about this trial