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New device zaps kidney nerves to lower blood pressure in Real-World study

NCT ID NCT06297291

Disease control Sponsor: ReCor Medical, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This study is tracking 1,000 patients with high blood pressure who receive the Paradise Ultrasound Renal Denervation treatment. The procedure uses ultrasound energy to calm overactive nerves near the kidneys, which can help lower blood pressure. Researchers are monitoring blood pressure changes and medication use over time to see how well the device works in everyday medical practice.

What this could mean

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

Active substance
Paradise Ultrasound Renal Denervation System (a catheter-based device that uses ultrasound energy to calm nerves near the kidneys)
What this could lead to
If successful, this study could confirm that the Paradise system is a safe and effective long-term option for lowering blood pressure in patients who cannot control it with lifestyle changes or medication.
What could go wrong
This is a post-approval observational study, not a randomized controlled trial, so results may be less definitive. The procedure carries risks such as injury to blood vessels or kidneys, and some patients may not experience significant blood pressure reduction.

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.

Participants

About 1,000 people

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

Started

Jun 2024

Expected to finish

Jul 2031

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.

Who is studied

Hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control BP will be identified from the general population by the enrolling center. Subjects enrolled in the RADIANCE CAP study will be transferred to the US GPS study after completion of their 12-month follow-up visit in the RADIANCE CAP study, to complete the remainder of the long-term annual follow-up visits under the post approval study protocol.

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.

Inclusion Criteria: * Signed and dated study informed consent * Documented history of hypertension * Documented history of prior or current antihypertensive medication(s) * Mean seated office systolic BP at screening ≥ 140 mmHg * Mean pre-procedure home systolic BP of ≥ 135 mmHg * Estimated glomerular filtration rate (eGFR) of ≥30 mL/min/m2 RADIANCE CAP patients must provide signed and dated informed consent for inclusion in long-term follow-up. No other criteria are required for inclusion. Exclusion Criteria: Patients who meet the following will be excluded from participation: * Patient lacks appropriate renal anatomy for any treatment with the Paradise Catheter * Patient under the age of 18 years old at the time of consent * Patient is pregnant * Patients with transplanted kidney * Presence of abnormal kidney (or secreting adrenal) tumors To confirm eligibility for treatment with the Paradise System, the following contraindications listed in the IFU may be determined at the time of procedure prior to treatment: * Renal arteries with diameter \< 3mm and \> 8mm * Renal artery with fibromuscular dysplasia (FMD) * Stented renal artery * Renal artery aneurysm * Renal artery diameter stenosis \>30% * Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder essential hypertension hypertensive disorder vascular disorder

As listed by the trial registrant

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

Cardiovascular diseases Hypertension Vascular diseases

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

  • Albany Medical Center

    RECRUITING

    Albany, New York, 12208, United States

  • Ascension Sacred Heart

    RECRUITING

    Pensacola, Florida, 32504, United States

  • Ascension Saint Thomas

    RECRUITING

    Nashville, Tennessee, 37205, United States

  • Ascension Seton

    RECRUITING

    Austin, Texas, 78705, United States

  • Ascension via Christi St. Francis

    RECRUITING

    Wichita, Kansas, 67214, United States

  • Bridgeport Hosptial

    RECRUITING

    Bridgeport, Connecticut, 06610, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Columbia University Medical Center/New York Presbyterian Hospital

    RECRUITING

    New York, New York, 10032, United States

  • Dallas VAMC

    RECRUITING

    Dallas, Texas, 75216, United States

  • Durham VA Health System

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Henry Ford St. John Hospital

    RECRUITING

    Detroit, Michigan, 48236, United States

  • Inova Fairfax Hospital

    RECRUITING

    Fairfax, Virginia, 22042, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medical Center of the Rockies

    RECRUITING

    Loveland, Colorado, 80538, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Metropolitan Heart & Vascular Institute

    RECRUITING

    Coon Rapids, Minnesota, 55433, United States

  • NYU Langone Health - Bellevue Hosptial

    RECRUITING

    New York, New York, 10016, United States

  • NewYork-Presbyterian Brooklyn Methodist Hospital

    RECRUITING

    Brooklyn, New York, 11215, United States

  • Pacific Heart Institute

    RECRUITING

    Santa Monica, California, 90404, United States

    Contact Email: •••••@•••••

  • Penn Medicine

    RECRUITING

    Phildelphia, Pennsylvania, 19104, United States

  • Prisma Health Richland Hospital

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • Rocky Mountain Regional VAMC

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Saint Luke's Mid America Heart Institute

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Southern Illinois University, Memorial Medical Center

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Spartanburg Regional Medical Center

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • St. Mark's Hospital

    RECRUITING

    Salt Lake City, Utah, 84124, United States

  • Stony Brook Medicine

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Sutter Institute for Medical Research

    RECRUITING

    Sacramento, California, 95816, United States

  • Swedish Medical Center

    RECRUITING

    Seattle, Washington, 98122, United States

  • TCR Institute

    RECRUITING

    Kingwood, Texas, 77339, United States

  • Tampa Cardiovascular Interventions and Research

    RECRUITING

    Tampa, Florida, 33614, United States

  • The Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • The Cardiac & Vascular Institute

    RECRUITING

    Gainesville, Florida, 32605, United States

  • Tibor Rubin VA Medical Center

    RECRUITING

    Long Beach, California, 90822, United States

  • Touro Infirmary

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • UC Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • UPMC Harrisburg

    RECRUITING

    Harrisburg, Pennsylvania, 17110, United States

  • University at Buffalo

    RECRUITING

    Buffalo, New York, 14203, United States

  • University of Miami Health System

    RECRUITING

    Miami, Florida, 33136, United States

  • University of North Carolina at Chapel Hill School of Medicine

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Virtua Health

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • Wellstar Kennestone Hospital

    RECRUITING

    Marietta, Georgia, 30060, United States

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