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

Not Applicable

Recruiting

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Device: V-Wave Interatrial Shunt

• Registration Number: NCT03838445
• Lead Sponsor: V-Wave Ltd

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-12
• Study Start: 2020-02-14
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Primary Completion: 2024-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion 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.

Main

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therapy: V-Wave Shunt	V-Wave Interatrial Shunt	Treatment arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation.

Primary Outcome Measures

Name	Time	Method
Safety-Percentage of Treatment patients experiencing major device-related adverse events	3 months	Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation
Safety-Percentage of Treatment patients experiencing any major adverse event	3 months	Percentage of Treatment group patients experiencing any Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation
Procedure Success-Percentage of patients successfully implanted with study device	3 months	Percentage of patients successfully implanted with the study device at the intended location across the interatrial septum during the index procedure compared to patients with attempted implantations
Device Success-Percentage of patients implanted with right to left interatrial flow	3 months	Percentage of patients successfully implanted with the study device with right to left interatrial flow on echocardiography at 3 months

Secondary Outcome Measures

Name	Time	Method
Freedom from device related MACNE at 1 and 12 months after implantation	1 and 12 months	Freedom from device related Major Adverse Cardiac and Neurologic Events at 1 and 12 months after implantation.
Improvement in WHO Functional Class between baseline and 12 months	12 months	Improvement in World Health Organization Functional Class between baseline and 12 months.
Improvement in Quality of Life between baseline and 12 months	12 months	Improvement in Quality of Life as measured by the CAMPHOR questionnaire
Improvement in Exercise Capacity between baseline and 12 months	12 months	Improvement in Exercise Capacity measured by the six minute hall walk test from baseline to 12 months

Trial Locations

Locations (5)

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval; 🇨🇦 Québec, Canada

Instituto Nacional de Cardiologia; 🇲🇽 Mexico City, Mexico

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

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Keck Medical Center of USC; 🇺🇸 Los Angeles, California, United States