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V-Wave Interatrial Shunt for Pulmonary Hypertension (RELIEVE-PAH Trial)
RELIEVE-PAH Trial Summary
This trial is testing a new device to treat pulmonary arterial hypertension in humans. The objectives are to assess its safety and effectiveness.
RELIEVE-PAH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRELIEVE-PAH Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RELIEVE-PAH Trial Design
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Who is running the clinical trial?
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- My heart condition severely limits my activity or I'm unable to do any activity without discomfort.My veins are not suitable for a specific heart procedure.I have been on the strongest PAH medication I can tolerate for over 3 months.Your oxygen level is less than 90% when measured at rest without extra oxygen, adjusted for the altitude you are at.Your right atrial pressure is consistently higher than 20 mmHg.Your heart's pumping function is less than 40%.I have severe lung disease that affects my breathing.I have organ dysfunction not related to right heart failure.My heart and breathing rates are stable.My PAH is related to a specific cause like idiopathic, HIV, or heart disease.You have a heart condition that would make it impossible to implant a shunt in a certain part of your heart.
- Group 1: Therapy: V-Wave Shunt
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is enrollment still possible for those interested in joining this experiment?
"Affirmative. Clinicaltrial.gov provides evidence that this study, which was initially posted on February 14th 2020, is still engaging participants. A total of 20 individuals will be recruited from 4 different facilities for the trial."
What is the main goal of this clinical experiment?
"Through this 3-month trial, the primary aim is to determine how safe the treatment is in terms of major device-related adverse events. Secondary objectives include assessing improvements in exercise capacity via a 6 minute hall walk test, WHO Functional Class ranking, and quality of life according to CAMPHOR questionnaire data."
In what specific sites is this trial being administered?
"Four locations are currently accepting enrolment for this trial: Los Angeles, Columbus, Québec and 4 additional sites. It is recommended that you select the site nearest to your current abode in order to minimize commuting hardships if you choose to partake."
What is the enrollment capacity of this particular research endeavor?
"Affirmative. According to the clinicaltrials.gov website, this medical experiment is currently recruiting participants and has been since February 14th 2020. The last edit was made on August 29th 2022 and there are 4 locations involved in the study that require 20 volunteers each."
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