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Tiny heart implant aims to ease strain in rare lung disease

NCT ID NCT03838445

Disease control Sponsor: V-Wave Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests a small, permanent device called the V-Wave Interatrial Shunt in 9 people with severe pulmonary arterial hypertension (PAH). The device is placed in the heart during a minimally invasive procedure to create a small opening between the upper chambers, which may help relieve pressure on the right side of the heart. The main goals are to check safety and see if the device works as intended.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
V-Wave Interatrial Shunt (a permanent implant placed in the heart to create a small passage between upper chambers)
What this could lead to
If it works, this device could offer a new way to reduce strain on the right side of the heart and improve daily function for people with severe pulmonary arterial hypertension.
What could go wrong
This is a very early, first-in-human trial with only 9 participants. The device is permanent and carries risks like heart or blood vessel complications. Success in this small group may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9 people

The number who actually took part.

Started

Feb 2020

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Inclusion Criteria: 1. Group 1 PAH (idiopathic, connective tissue disease, HIV, corrected congenital heart disease). 2. 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. 3. Receiving maximal available and tolerable pharmacological PAH therapy ≥3 months at a stable dose for ≥1 month. Main Exclusion Criteria: 1. Resting oxygen saturation \<90 % without supplemental oxygen corrected for altitude. 2. Mean Right Atrial Pressure \>20 mmHg. 3. Severe restrictive or obstructive lung disease. 4. Evidence of organ dysfunction other than right heart failure. 5. Left ventricular ejection fraction \<40 %. 6. Anatomical anomaly on transesophageal echocardiography or intracardiac echocardiography that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum. 7. Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent. 8. Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria.

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension

Contacts and locations

Locations

  • Instituto Nacional de Cardiologia

    Mexico City, Mexico

  • Keck Medical Center of USC

    Los Angeles, California, 90033, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

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