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Device

V-Wave Interatrial Shunt for Pulmonary Hypertension (RELIEVE-PAH Trial)

N/A

Recruiting

Led By Victor Tapson, M.D.

Research Sponsored by V-Wave Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent

Severe restrictive or obstructive lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device to treat pulmonary arterial hypertension in humans. The objectives are to assess its safety and effectiveness.

Who is the study for?

This trial is for adults with severe pulmonary arterial hypertension, specifically those classified as WHO Functional Class III or IV. Participants must have been on stable PAH medication for at least 3 months and meet certain risk criteria. Exclusions include individuals with significant heart rhythm issues, low left ventricular ejection fraction, severe lung disease, specific anatomical anomalies, very low oxygen levels without support, or other organ dysfunction.

What is being tested?

The RELIEVE-PAH study is testing the V-Wave Interatrial Shunt device in patients with severe pulmonary arterial hypertension to assess its safety and performance. The goal is to see if this new treatment can help reduce symptoms of right ventricular failure by improving blood flow.

What are the potential side effects?

While not explicitly listed here, potential side effects may include complications from the implant procedure such as bleeding or infection, irregular heart rhythms due to shunt placement, worsening heart function if the device doesn't work properly and general risks associated with invasive cardiac procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart condition severely limits my activity or I'm unable to do any activity without discomfort.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My veins are not suitable for a specific heart procedure.

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I have severe lung disease that affects my breathing.

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I have organ dysfunction not related to right heart failure.

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My heart and breathing rates are stable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Procedure Success-Percentage of patients successfully implanted with study device

Safety-Percentage of Treatment patients experiencing any major adverse event

+1 more

Secondary study objectives

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

Improvement in Exercise Capacity between baseline and 12 months

Improvement in Quality of Life between baseline and 12 months

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Therapy: V-Wave ShuntExperimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met