Overview
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.
Eligibility
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.