Status:
RECRUITING
Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)
Lead Sponsor:
V-Wave Ltd
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, dev...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
February 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03838445
Start Date
February 14 2020
End Date
December 31 2026
Last Update
June 7 2024
Active Locations (5)
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1
Keck Medical Center of USC
Los Angeles, California, United States, 90033
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute
Columbus, Ohio, United States, 43210
4
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Canada