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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Keck Medical Center of USC
Los Angeles, California, United States
RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
RECRUITINGThe Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute
Columbus, Ohio, United States
Safety-Percentage of Treatment patients experiencing major device-related adverse events
Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation
Time frame: 3 months
Safety-Percentage of Treatment patients experiencing any major adverse event
Percentage of Treatment group patients experiencing any Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation
Time frame: 3 months
Procedure Success-Percentage of patients successfully implanted with study device
Percentage of patients successfully implanted with the study device at the intended location across the interatrial septum during the index procedure compared to patients with attempted implantations
Time frame: 3 months
Device Success-Percentage of patients implanted with right to left interatrial flow
Percentage of patients successfully implanted with the study device with right to left interatrial flow on echocardiography at 3 months
Time frame: 3 months
Freedom from device related MACNE at 1 and 12 months after implantation
Freedom from device related Major Adverse Cardiac and Neurologic Events at 1 and 12 months after implantation.
Time frame: 1 and 12 months
Improvement in Exercise Capacity between baseline and 12 months
Improvement in Exercise Capacity measured by the six minute hall walk test from baseline to 12 months
Time frame: 12 months
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Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Canada
WITHDRAWNInstituto Nacional de Cardiologia
Mexico City, Mexico
ACTIVE_NOT_RECRUITINGImprovement in WHO Functional Class between baseline and 12 months
Improvement in World Health Organization Functional Class between baseline and 12 months.
Time frame: 12 months
Improvement in Quality of Life between baseline and 12 months
Improvement in Quality of Life as measured by the SF-36 questionnaire
Time frame: 12 months
Improvement in Quality of Life between baseline and 12 months
Improvement in Quality of Life as measured by the CAMPHOR questionnaire
Time frame: 12 months