Back to results

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

Primary Purpose

Pulmonary Arterial Hypertension

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

V-Wave Interatrial Shunt

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Pulmonary Arterial Hypertension, PAH, Interatrial Shunt, Interatrial Shunting, Atrial Septostomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

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.

Main Exclusion Criteria:

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.
Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria.

Sites / Locations

Keck Medical Center of USCRecruiting
University of California, San FranciscoRecruiting
The Ohio State University Wexner Medical Center - Davis Heart & Lung Research InstituteRecruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Instituto Nacional de Cardiologia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapy: V-Wave Shunt

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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

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

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

Secondary Outcome Measures

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.

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

Improvement in WHO Functional Class between baseline and 12 months

Improvement in World Health Organization Functional Class between baseline and 12 months.

Improvement in Quality of Life between baseline and 12 months

Improvement in Quality of Life as measured by the SF-36 questionnaire

Improvement in Quality of Life between baseline and 12 months

Improvement in Quality of Life as measured by the CAMPHOR questionnaire

Full Information

NCT ID

NCT03838445

First Posted

February 6, 2019

Last Updated

August 27, 2023

Sponsor

V-Wave Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03838445

Brief Title

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

Acronym

RELIEVE-PAH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 14, 2020 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

V-Wave Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Arterial Hypertension

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Therapy: V-Wave Shunt

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

V-Wave Interatrial Shunt

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety-Percentage of Treatment patients experiencing major device-related adverse events

Description

Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation

Time Frame

3 months

Title

Safety-Percentage of Treatment patients experiencing any major adverse event

Description

Percentage of Treatment group patients experiencing any Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation

Time Frame

3 months

Title

Procedure Success-Percentage of patients successfully implanted with study device

Description

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

Time Frame

3 months

Title

Device Success-Percentage of patients implanted with right to left interatrial flow

Description

Percentage of patients successfully implanted with the study device with right to left interatrial flow on echocardiography at 3 months

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Description

Freedom from device related Major Adverse Cardiac and Neurologic Events at 1 and 12 months after implantation.

Time Frame

1 and 12 months

Title

Improvement in Exercise Capacity between baseline and 12 months

Description

Improvement in Exercise Capacity measured by the six minute hall walk test from baseline to 12 months

Time Frame

12 months

Title

Improvement in WHO Functional Class between baseline and 12 months

Description

Improvement in World Health Organization Functional Class between baseline and 12 months.

Time Frame

12 months

Title

Improvement in Quality of Life between baseline and 12 months

Description

Improvement in Quality of Life as measured by the SF-36 questionnaire

Time Frame

12 months

Title

Improvement in Quality of Life between baseline and 12 months

Description

Improvement in Quality of Life as measured by the CAMPHOR questionnaire

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main Inclusion Criteria: 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. Main Exclusion Criteria: 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. Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

William T. Abraham, M.D.

Phone

(818)629-2164

bill@vwavemedical.com

First Name & Middle Initial & Last Name or Official Title & Degree

Beverly Walker, MSN, NP

Phone

(818)629-2164

beverly@vwavemedical.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victor Tapson, M.D.

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Keck Medical Center of USC

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sivagini Ganesh, MD

First Name & Middle Initial & Last Name & Degree

Sivagini Ganesh, MD

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc Simon, MD

First Name & Middle Initial & Last Name & Degree

Marc Simon, MD

Facility Name

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

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Veronica Franco, MD

First Name & Middle Initial & Last Name & Degree

Veronica Franco, M.D.

Facility Name

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

City

Québec

Country

Canada

Individual Site Status

Withdrawn

Facility Name

Instituto Nacional de Cardiologia

City

Mexico City

Country

Mexico

Individual Site Status

Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs