Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)
RELIEVE-PAH TRIAL: REducing Right ventricuLar faIlure With thE V-waVe Shunt in Pulmonary Arterial Hypertension
V-Wave Ltd
20 participants
Feb 14, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria7
- 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.
Interventions
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.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT03838445