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Ultrasound zaps lung nerves to ease heart failure symptoms

NCT ID NCT06052072

Disease control Sponsor: Gradient Denervation Technologies 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early study is testing a device that uses ultrasound to ablate (calm) nerves in the pulmonary artery. The goal is to see if this procedure can improve quality of life for 50 people with heart failure and a specific type of pulmonary hypertension (Group 2). Participants will be followed for safety and changes in blood vessel resistance.

What this could mean

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

Active substance
Gradient Denervation System (ultrasound ablation device)
What this could lead to
If it works, this could offer a new way to manage heart failure and pulmonary hypertension, potentially improving daily life and reducing symptoms.
What could go wrong
This is a very early, small feasibility study with only 50 participants. The procedure carries risks like serious adverse events, and it is not yet known if it will provide lasting benefit.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Jul 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

22 to 85 years

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.

Inclusion Criteria: * Heart Failure with EF ≥ 40% (by TTE within last 3 months) * Mean Pulmonary Artery Pressure (mPAP) \>20 mmHg at rest * Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest * Pulmonary Capillary Wedge Pressure \> 15 mmHg (at rest) or \> 18 with passive leg raise * Cardiac index (CI) ≥ 1.7 L/min/m2 * NYHA Class II or III * Glomerular Filtration Rate (GFR) ≥ 25 ml/min * Stable, guideline directed medical treatment, including controlled volume status for a minimum of 1 months prior treatment Exclusion Criteria: * Ambulatory with a Life expectancy of \< 1 years * Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel * Unable to tolerate right heart catheterization * Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device * Severe aortic, mitral or pulmonary valve regurgitation * Tricuspid regurgitation in conjunction with the presence of cirrhosis or congestive hepatopathy * Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)

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Conditions

The condition(s) this trial relates to.

diastolic heart failure heart failure pulmonary hypertension

As listed by the trial registrant

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

Group 2 pulmonary hypertension Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aurora Health

    Milwaukee, Wisconsin, 53215, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Duke University

    Durham, North Carolina, 27708, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • University of Wisconsin

    Madison, Wisconsin, 53705, United States

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