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NCT03838445 · ClinicalTrials.gov registry record · NA

Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)

A NA study of Pulmonary Arterial Hypertension, sponsored by V-Wave.

Recruiting
Registry status
NA
Development phase
20
Enrollment target
5
Study locations

NCT03838445: Recruiting NA study of Pulmonary Arterial Hypertension, sponsored by V-Wave.

NCT03838445 is a NA study of Pulmonary Arterial Hypertension that is actively recruiting participants, run by V-Wave. The registered enrollment target is 20 participants, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03838445, a NA study of Pulmonary Arterial Hypertension, is actively recruiting participants, sponsored by V-Wave.

RECRUITING
Registry status
NA
Development phase
20 participants
Enrollment target
5
Study locations

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.

Primary Outcome

Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation

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

FieldValue
Enrollment Target 20 participants
Start Date 2020-02-14
Est. Completion 2026-12-31
Phase NA
V-Wave

2 total trials

What NCT03838445 shows while recruiting

NCT03838445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (96% lower).

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.

NCT03838445 lists 5 locations in 3 states (California, Other, Ohio).

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.

What interventions are being tested in trial NCT03838445?

The interventions under investigation include: V-Wave Interatrial Shunt (DEVICE).

Who is sponsoring clinical trial NCT03838445?

This trial is sponsored by V-Wave, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Pulmonary Arterial Hypertension

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03838445's enrollment target sits among peer trials

20 49th of 63 higher than 10 of 63 other Pulmonary Arterial Hypertension trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03838445, the US trial registry maintained by the National Library of Medicine. NCT03838445 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.