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New device zaps kidney and liver nerves to tame high blood pressure

NCT ID NCT06907147

Disease control Sponsor: Medtronic Vascular Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device that uses radiofrequency energy to disrupt nerve signals in the kidney and liver arteries, aiming to lower blood pressure in people with uncontrolled hypertension. About 175 adults aged 18-80 with high blood pressure despite medication will be enrolled. The main goal is to see if the procedure is safe and reduces blood pressure over time.

What this could mean

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

Active substance
Multi-Organ Denervation Gemini System (a device that uses radiofrequency energy to disrupt nerve signals in the kidney and liver arteries)
What this could lead to
If it works, this could offer a new, drug-free way to control high blood pressure and reduce the risk of heart and kidney problems.
What could go wrong
This is an early pilot study with only 175 people, so results may not apply to everyone. The procedure involves artery access and carries risks like bleeding or vessel damage.

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 175 people

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

Started

May 2025

Expected to finish

Dec 2029

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 to 80 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: All Subjects (both cohorts): 1. ≥18 and ≤80 years of age. 2. Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and \<180 mmHg and an office DBP ≥ 90 mmHg. 3. 24-hour average SBP ≥140 mmHg and \<170 mmHg measured by ABPM at Baseline. Exclusion Criteria: 1. Individual lacks appropriate renal artery OR common hepatic artery anatomy. 2. Prior renal or hepatic denervation. 3. History of NYHA Class III or IV heart failure within 6 months of screening visit. 4. Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability. 5. Documented Type 1 diabetes or use of insulin within 6 months. 6. Secondary cause of hypertension. 7. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement. 8. Estimated glomerular filtration rate (eGFR) of \<40 9. Pregnant, nursing or planning to become pregnant during the study. 10. Primary pulmonary arterial hypertension. 11. History or evidence of active / suspected chronic liver or biliary disease. 12. Current or chronic pancreatitis.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Chronic Disease chronic kidney disease chronic renal failure syndrome diabetes mellitus Disease Attributes hypertensive disorder kidney disorder kidney failure Pathologic Processes vascular disorder

As listed by the trial registrant

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

Cardiovascular diseases Chronic kidney diseases Diabetes mellitus Hypertension Vascular diseases

How to take part

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

  1. The places running it

    18 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • BayCare Health System Mease Countryside Hospital

    RECRUITING

    Safety Harbor, Florida, 34695, United States

  • Baylor Heart & Vascular Hospital

    RECRUITING

    Dallas, Texas, 75226, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Henry Ford Providence Hospital

    RECRUITING

    Southfield, Michigan, 48075-4818, United States

  • Hippokration General Hospital

    RECRUITING

    Athens, 11527, Greece

  • North Mississippi Medical Center

    RECRUITING

    Tupelo, Mississippi, 38801-4934, United States

  • Orlando Health Heart & Vascular Institute

    RECRUITING

    Orlando, Florida, 32806, United States

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309-1281, United States

  • Renown Regional Medical Center

    RECRUITING

    Reno, Nevada, 89502, United States

  • Royal Perth Hospital (Dobney Hypertension Centre)

    RECRUITING

    Perth, 6000, Australia

  • Stanford Hospital and Clinics

    RECRUITING

    Stanford, California, 94305, United States

  • UT Health East Texas

    RECRUITING

    Tyler, Texas, 75701, United States

  • University Hospital Basel

    RECRUITING

    Basel, 4031, Switzerland

  • University Hospital Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • University Hospital of Galway

    RECRUITING

    Galway, H91 YR71, Ireland

  • University of North Carolina (UNC) Memorial Hospital

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Universität des Saarlandes

    RECRUITING

    Homburg, 66421, Germany

  • Virtua Our Lady of Lourdes Hospital

    RECRUITING

    Camden, New Jersey, 08103, United States

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