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

NCT03838445 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CL7012
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 3

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial Hypertension; PAH; Interatrial Shunt; Interatrial Shunting; Atrial Septostomy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Freedom from device related MACNE at 1 and 12 months after implantation

  1 and 12 months

• Improvement in Exercise Capacity between baseline and 12 months

  12 months

• Improvement in WHO Functional Class between baseline and 12 months

  12 months

• Improvement in Quality of Life between baseline and 12 months

  12 months

• Improvement in Quality of Life between baseline and 12 months

  12 months

Study Arms (1)

Therapy: V-Wave Shunt

EXPERIMENTAL

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

Interventions

V-Wave Interatrial Shunt DEVICE

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.

Therapy: V-Wave Shunt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group 1 PAH (idiopathic, connective tissue disease, HIV, corrected congenital heart disease).
• 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.
• Receiving maximal available and tolerable pharmacological PAH therapy ≥3 months at a stable dose for ≥1 month.

You may not qualify if:

• Resting oxygen saturation \<90 % without supplemental oxygen corrected for altitude.
• Mean Right Atrial Pressure \>20 mmHg.
• Severe restrictive or obstructive lung disease.
• Evidence of organ dysfunction other than right heart failure.
• Left ventricular ejection fraction \<40 %.
• Anatomical anomaly on transesophageal echocardiography or intracardiac echocardiography that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum.
• Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent.

Sponsors & Collaborators

• V-Wave Ltd: lead

Study Sites (3)

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Instituto Nacional de Cardiologia

Mexico City, Mexico

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Victor Tapson, M.D.

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 12, 2019
• Study Start: February 14, 2020
• Primary Completion: June 30, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

ME (1); US (2)