← Back to Search

Device

V-Wave Interatrial Shunt for Pulmonary Hypertension (RELIEVE-PAH Trial)

N/A
Recruiting
Led By Victor Tapson, M.D.
Research Sponsored by V-Wave Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 12 months
Awards & highlights

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.

Who is the study for?
This trial is for adults with severe pulmonary arterial hypertension, specifically those classified as WHO Functional Class III or IV. Participants must have been on stable PAH medication for at least 3 months and meet certain risk criteria. Exclusions include individuals with significant heart rhythm issues, low left ventricular ejection fraction, severe lung disease, specific anatomical anomalies, very low oxygen levels without support, or other organ dysfunction.Check my eligibility
What is being tested?
The RELIEVE-PAH study is testing the V-Wave Interatrial Shunt device in patients with severe pulmonary arterial hypertension to assess its safety and performance. The goal is to see if this new treatment can help reduce symptoms of right ventricular failure by improving blood flow.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include complications from the implant procedure such as bleeding or infection, irregular heart rhythms due to shunt placement, worsening heart function if the device doesn't work properly and general risks associated with invasive cardiac procedures.

RELIEVE-PAH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My heart condition severely limits my activity or I'm unable to do any activity without discomfort.
Select...
I have been on the strongest PAH medication I can tolerate for over 3 months.
Select...
My PAH is related to a specific cause like idiopathic, HIV, or heart disease.

RELIEVE-PAH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Device Success-Percentage of patients implanted with right to left interatrial flow
Procedure Success-Percentage of patients successfully implanted with study device
Safety-Percentage of Treatment patients experiencing any major adverse event
+1 more
Secondary outcome measures
Freedom from device related MACNE at 1 and 12 months after implantation
Improvement in Exercise Capacity between baseline and 12 months
Improvement in Quality of Life between baseline and 12 months
+1 more

RELIEVE-PAH Trial Design

1Treatment groups
Experimental Treatment
Group I: Therapy: V-Wave ShuntExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

V-Wave LtdLead Sponsor
4 Previous Clinical Trials
631 Total Patients Enrolled
Victor Tapson, M.D.Principal InvestigatorCedars-Sinai Medical Center

Media Library

V-Wave Interatrial Shunt (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03838445 — N/A
Pulmonary Arterial Hypertension Research Study Groups: Therapy: V-Wave Shunt
Pulmonary Arterial Hypertension Clinical Trial 2023: V-Wave Interatrial Shunt Highlights & Side Effects. Trial Name: NCT03838445 — N/A
V-Wave Interatrial Shunt (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03838445 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~1 spots leftby Jun 2024