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

Pulmonary Arterial Hypertension Clinical Trial

— RELIEVE-PAH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03838445
• Other study ID #: CL7012
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: V-Wave Ltd
• Contact: William T. Abraham, M.D.
• Phone: (818)629-2164
• Email: bill[@]vwavemedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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.

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval	Québec
Mexico	Instituto Nacional de Cardiologia	Mexico City
United States	The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute	Columbus	Ohio
United States	Keck Medical Center of USC	Los Angeles	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
V-Wave Ltd

Countries where clinical trial is conducted

United States,  Canada,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Improvement in WHO Functional Class between baseline and 12 months	Improvement in World Health Organization Functional Class between baseline and 12 months.	12 months
Secondary	Improvement in Quality of Life between baseline and 12 months	Improvement in Quality of Life as measured by the SF-36 questionnaire	12 months
Secondary	Improvement in Quality of Life between baseline and 12 months	Improvement in Quality of Life as measured by the CAMPHOR questionnaire	12 months