Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH) (RELIEVE-PAH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03838445|
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Device: V-Wave Interatrial Shunt||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||RELIEVE-PAH TRIAL: REducing Right ventricuLar faIlure With thE V-waVe Shunt in Pulmonary Arterial Hypertension|
|Estimated Study Start Date :||October 30, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: Therapy: V-Wave Shunt
Treatment arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation.
Device: V-Wave Interatrial Shunt
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.
- Safety-Percentage of Treatment patients experiencing major device-related adverse events [ Time Frame: 3 months ]Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation
- Safety-Percentage of Treatment patients experiencing any major adverse event [ Time Frame: 3 months ]Percentage of Treatment group patients experiencing any Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation
- Procedure Success-Percentage of patients successfully implanted with study device [ Time Frame: 3 months ]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
- Device Success-Percentage of patients implanted with right to left interatrial flow [ Time Frame: 3 months ]Percentage of patients successfully implanted with the study device with right to left interatrial flow on echocardiography at 3 months
- Freedom from device related MACNE at 1 and 12 months after implantation [ Time Frame: 1 and 12 months ]Freedom from device related Major Adverse Cardiac and Neurologic Events at 1 and 12 months after implantation.
- Improvement in Exercise Capacity between baseline and 12 months [ Time Frame: 12 months ]Improvement in Exercise Capacity measured by the six minute hall walk test from baseline to 12 months
- Improvement in WHO Functional Class between baseline and 12 months [ Time Frame: 12 months ]Improvement in World Health Organization Functional Class between baseline and 12 months.
- Improvement in Quality of Life between baseline and 12 months [ Time Frame: 12 months ]Improvement in Quality of Life as measured by the SF-36 questionnaire
- Improvement in Quality of Life between baseline and 12 months [ Time Frame: 12 months ]Improvement in Quality of Life as measured by the CAMPHOR questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838445
|Contact: William T. Abraham, M.D.||(818)email@example.com|
|Contact: Beverly Walker, MSN, NP||(818)firstname.lastname@example.org|
|United States, Ohio|
|The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute||Not yet recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Joe Santiago, RRT, CCRP 614-366-4593 Joseph.email@example.com|
|Principal Investigator: Veronica Franco, M.D.|
|Principal Investigator:||Victor Tapson, M.D.||Cedars-Sinai Medical Center|