RECRUITING

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

Conditions

Pulmonary Arterial Hypertension PAH Interatrial Shunt Interatrial Shunting Atrial Septostomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-02-14

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03838445

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

William T. Abraham, M.D.

CONTACT

(818)629-2164

bill@vwavemedical.com

Beverly Walker, MSN, NP

CONTACT

(818)629-2164

beverly@vwavemedical.com

Principal Investigator

Victor Tapson, M.D.

PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Study Locations (Sites)

Keck Medical Center of USC

Los Angeles, California, 90033

United States

University of California, San Francisco

San Francisco, California, 94143

United States

The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: V-Wave Ltd

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-14

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2020-02-14

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Pulmonary Arterial Hypertension
PAH
Interatrial Shunt
Interatrial Shunting
Atrial Septostomy

Additional Relevant MeSH Terms

Pulmonary Arterial Hypertension