Clinical trial NCT03838445: Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)
Official title: RELIEVE-PAH TRIAL: REducing Right ventricuLar faIlure With thE V-waVe Shunt in Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension
PAH
Interatrial Shunt
Interatrial Shunting
Atrial Septostomy
Lead sponsor: V-Wave Ltd
Sponsor class: INDUSTRY
First posted: 2019-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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, device performance and possible signals of clinical effectiveness.

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 and followed at regular intervals for 1 year and then annually for a total of 5 years post implant.

Eligibility criteria: Main Inclusion Criteria:

1. Group 1 PAH (idiopathic, connective tissue disease, HIV, corrected congenital heart disease).
2. 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.
3. Receiving maximal available and tolerable pharmacological PAH therapy ≥3 months at a stable dose for ≥1 month.

Main Exclusion Criteria:

1. Resting oxygen saturation \<90 % without supplemental oxygen corrected for altitude.
2. Mean Right Atrial Pressure \>20 mmHg.
3. Severe restrictive or obstructive lung disease.
4. Evidence of organ dysfunction other than right heart failure.
5. Left ventricular ejection fraction \<40 %.
6. Anatomical anomaly on transesophageal echocardiography or intracardiac echocardiography that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum.
7. Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent.
8. Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria.

Primary outcomes:
measure: Safety-Percentage of Treatment patients experiencing major device-related adverse events
timeFrame: 3 months
measure: Safety-Percentage of Treatment patients experiencing any major adverse event
timeFrame: 3 months
measure: Procedure Success-Percentage of patients successfully implanted with study device
timeFrame: 3 months
measure: Device Success-Percentage of patients implanted with right to left interatrial flow
timeFrame: 3 months
Secondary outcomes:
measure: Freedom from device related MACNE at 1 and 12 months after implantation
timeFrame: 1 and 12 months
measure: Improvement in Exercise Capacity between baseline and 12 months
timeFrame: 12 months
measure: Improvement in WHO Functional Class between baseline and 12 months
timeFrame: 12 months
measure: Improvement in Quality of Life between baseline and 12 months
timeFrame: 12 months
measure: Improvement in Quality of Life between baseline and 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute
state: Ohio
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiologia
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Victor Tapson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: