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Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)
NCT03838445 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE V-Wave Interatrial Shunt
Study Locations (5)
California
- Keck Medical Center of USC — Los Angeles
- University of California, San Francisco — San Francisco
Other
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec
- Instituto Nacional de Cardiologia — Mexico City
Ohio
- The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-02-14 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03838445
The ClinicalTrials.gov registry entry for NCT03838445 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is V-Wave, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 1 intervention — of which V-Wave Interatrial Shunt is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03838445 reports 5 study locations spanning 3 distinct geographic areas — top geographies include California, Other, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03838445 about?
NCT03838445 is a clinical study titled "Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)". 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.
What is the current status of trial NCT03838445?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2020-02-14. Estimated completion is 2026-12-31.
What conditions does trial NCT03838445 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03838445?
The interventions under investigation include: V-Wave Interatrial Shunt (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03838445?
This trial is sponsored by V-Wave, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03838445 being conducted?
This trial has 5 study locations across California, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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