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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Device: V-Wave Interatrial Shunt


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy: V-Wave Shunt<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAH, Pulmonary Arterial Hypertension, Interatrial Shunt, Interatrial Shunting, Atrial Septostomy