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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    20
  • sponsor
    V-Wave Ltd
Updated on 27 August 2021
hypertension
connective tissue disease
right ventricular failure

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.

Details
Condition Pulmonary Arterial Hypertension
Treatment V-Wave Interatrial Shunt
Clinical Study IdentifierNCT03838445
SponsorV-Wave Ltd
Last Modified on27 August 2021

Eligibility

Yes No Not Sure

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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