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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Device: V-Wave Interatrial Shunt

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William T. Abraham, M.D.; Phone Number: (818)629-2164; Email: bill@vwavemedical.com
• Study Contact Backup: Name: Beverly Walker, MSN, NP; Phone Number: (818)629-2164; Email: beverly@vwavemedical.com

Study Locations

• Canada
  • Québec, Canada
    • Withdrawn
    • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
• Mexico
  • Mexico City, Mexico
    • Active, not recruiting
    • Instituto Nacional de Cardiologia
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Keck Medical Center of USC
      • Contact: Sivagini Ganesh, MD
      • Principal Investigator: Sivagini Ganesh, MD
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Marc Simon, MD
      • Principal Investigator: Marc Simon, MD
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Withdrawn
      • The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Main 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapy: V-Wave 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.	Device: V-Wave Interatrial Shunt; The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovals and straddles the interatrial septum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety-Percentage of Treatment patients experiencing major device-related adverse events	Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation	3 months
Safety-Percentage of Treatment patients experiencing any major adverse event	Percentage of Treatment group patients experiencing any Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation	3 months
Procedure Success-Percentage of patients successfully implanted with study device	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	3 months
Device Success-Percentage of patients implanted with right to left interatrial flow	Percentage of patients successfully implanted with the study device with right to left interatrial flow on echocardiography at 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from device related MACNE at 1 and 12 months after implantation	Freedom from device related Major Adverse Cardiac and Neurologic Events at 1 and 12 months after implantation.	1 and 12 months
Improvement in Exercise Capacity between baseline and 12 months	Improvement in Exercise Capacity measured by the six minute hall walk test from baseline to 12 months	12 months
Improvement in WHO Functional Class between baseline and 12 months	Improvement in World Health Organization Functional Class between baseline and 12 months.	12 months
Improvement in Quality of Life between baseline and 12 months	Improvement in Quality of Life as measured by the SF-36 questionnaire	12 months
Improvement in Quality of Life between baseline and 12 months	Improvement in Quality of Life as measured by the CAMPHOR questionnaire	12 months

Collaborators and Investigators

• Sponsor: V-Wave Ltd
• Investigators: Principal Investigator: Victor Tapson, M.D., Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pulmonary Arterial Hypertension; PAH; Interatrial Shunt; Interatrial Shunting; Atrial Septostomy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Pulmonary Arterial Hypertension
• Other Study ID Numbers: CL7012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes