Zapping kidney nerves could tame tough blood pressure

NCT ID NCT02649426

Disease control Sponsor: ReCor Medical, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device that uses ultrasound to disrupt overactive nerves in the kidneys, which can drive high blood pressure. About 282 adults with hypertension will either get the real procedure or a sham (fake) procedure. The goal is to see if this treatment safely lowers blood pressure, possibly offering an alternative to daily pills.

What this could mean

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

Active substance: Paradise Renal Denervation Ultrasound System (device procedure)
What this could lead to: If it works, this could offer a new, drug-free option to help control high blood pressure.
What could go wrong: This is an early-stage study with a small number of participants. The procedure may not lower blood pressure enough, and there are risks from the catheter procedure itself.

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

282 people

The number who actually took part.

Started

Mar 2016

Expected to finish

May 2027

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 75 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.

TRIO and SOLO Inclusion Criteria: * Appropriately signed and dated informed consent * Age ≥18 and ≤75 years at time of consent * Documented history of essential hypertension * SOLO Cohort only: Either an average seated office BP \< 180/110 mmHg at screening visit while on a stable regimen of 1 or 2 antihypertensive medications for at least 4 weeks prior to consent or an average seated office BP ≥ 140/90 mmHg \<180/110 mmHg despite lifestyle measures on no antihypertensive medications * TRIO Cohort only: Average seated office BP ≥ 140/90 mmHg at screening visit while on a stable regimen of at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent * Documented daytime ABP ≥ 135/85 mmHg and \< 170/105 mmHg after 4-week washout/run-in period (SOLO cohort) or after 4-week stabilization period (TRIO cohort) * Suitable renal anatomy compatible with the renal denervation procedure and documented by renal CTA or MRA of good quality performed within one year prior to consent (a CTA or MRA will be obtained in patients without a recent (≤1 year) renal imaging) * Able and willing to comply with all study procedures Solo Exclusion Criteria: * Renal artery anatomy on either side, ineligible for treatment including: * Main renal artery diameter \< 4 mm and \> 8 mm * Main renal artery length \< 25 mm * A single functioning kidney * Presence of abnormal kidney (or secreting adrenal) tumors * Renal artery with aneurysm * Pre-existing renal stent or history of renal artery angioplasty * Prior renal denervation procedure * Fibromuscular disease of the renal arteries * Presence of renal artery stenosis of any origin ≥ 30% * Accessory arteries with diameter ≥ 2mm \<4 mm and \> 8 mm\* * Evidence of active infection within 7 days of procedure * Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter * Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%) * Documented history of chronic active inflammatory bowel disorders such as Chrohn's disease or ulcerative colitis * eGFR of \<40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula) * Brachial circumference ≥ 42 cm * Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) * Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV) * Documented confirmed episode(s) of stable or unstable angina * Documented repeat (\>1) hospitalization for hypertensive crisis within the prior 12 months * Prescribed to any standard antihypertensive of cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health * Documented history of persistent or permanent atrial tachyarrhythmia * Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator) * Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. * Primary pulmonary hypertension * Documented contraindication or allergy to contrast medium not amenable to treatment * Limited life expectancy of \< 1 year at the discretion of the Investigator * Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders (e.g. night shift workers) * Pregnant, nursing or planning to become pregnant (negative pregnancy test required, documented within a maximum of 7 days prior to procedure for all women of child bearing potential. Documentation of effective contraception is also required for women of child bearing potential) Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional Registries is acceptable) TRIO Exclusion Criteria * Renal artery anatomy on either side, ineligible for treatment including: * Main renal artery diameter \< 3.5 mm and \> 8 mm * Main renal artery length \< 20 mm * A single functioning kidney * Presence of abnormal kidney tumors * Renal artery with aneurysm * Pre-existing renal stent or history of renal artery angioplasty * Pre-existing aortic stent or history of aortic aneurysm * Prior renal denervation procedure * Fibromuscular disease of the renal arteries * Presence of renal artery stenosis of any origin ≥ 30% * Accessory arteries with diameter ≥2 mm \<3.5 mm and \> 8 mm\* * Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter * Evidence of active infection within 7 days of procedure * Secondary hypertension not including sleep apnea (documented through clinical work up within the 12 months prior to consent- see protocol body for details) * Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%) * Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis * eGFR of \<40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula) * Brachial circumference ≥ 42 cm * Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) within 3 months prior to consent * Any history of severe cardiovascular event (e.g. myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV) within 3 months prior to consent * Documented repeat (\>1) hospitalization for hypertensive crisis within the prior 3 months * Documented confirmed episode(s) of unstable angina within 3 months prior to consent * Documented intolerance or contraindication for any of the antihypertensive drugs prescribed as a requirement of the study protocol * Prescribed to any standard anti-hypertensive CV medication (other than beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health * Documented history of persistent or permanent atrial tachyarrhythmia * Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator) * Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. * Primary pulmonary hypertension * Documented contraindication or allergy to contrast medium not amenable to treatment * Limited life expectancy of \< 1 year at the discretion of the Investigator * Night shift workers * Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders * Pregnant, nursing or planning to become pregnant (documented negative pregnancy test required documented within a maximum of 7 days prior to procedure for all women of child bearing potential. Documentation of effective contraception is also required for women of child bearing potential) * Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional Registries is acceptable)

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Conditions

The condition(s) this trial relates to.

essential hypertension hypertensive disorder vascular disorder

As listed by the trial registrant

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

Hypertension Vascular diseases

Contacts and locations

Locations

CHRU Lille - Institut Coeur Poumon

Lille, 59000, France
Cedars-Sinai Medical Center

Los Angeles, California, 90211, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Clinique Pasteur

Toulouse, 31300, France
Cliniques Universitaires St Luc

Brussels, 1200, Belgium
Columbia University / NewYork Presbyterian Hospital

New York, New York, 10032, United States
Conquest Hospital - Hastings

Hastings, TN37 7RD, United Kingdom
Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States
Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States
Erasmus Medical Center

Rotterdam, 3015 CE, Netherlands
Franciscan Health Indianapolis

Indianapolis, Indiana, 46237, United States
Hôpital Européen Georges-Pompidou

Paris, 75015, France
Hôpital Saint-André - CHU Bordeaux

Bordeaux, 33000, France
Hôpital de la Croix Rousse

Lyon, 69004, France
Imperial College London, Hammersmith Hospital

London, England, SW7 2AZ, United Kingdom
Institute of Cardiology

Warsaw, 04-628, Poland
Katholisches Klinikum Mainz

Mainz, 55131, Germany
Leipzig Heart Center

Leipzig, 04289, Germany
Maastricht University Hospital

Maastricht, 6229 HX, Netherlands
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Medical University of Gdansk

Gdansk, 80-952, Poland
Medical University of South Carolina

Charleston, South Carolina, 29403, United States
Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States
New York University School of Medicine

New York, New York, 10010, United States
Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom
Ochsner Heart and Vascular Insitute

New Orleans, Louisiana, 70121, United States
Renown Institute for Heart& Vascular Health

Reno, Nevada, 89502, United States
Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom
Royal Devon and Exeter Hospital (Wonford)

Exeter, EX2 5DW, United Kingdom
Sana Kliniken Lübeck GmbH

Lübeck, 23560, Germany
Southern Illinois University Medicine

Springfield, Illinois, 62794, United States
St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom
Stamford Hospital

Stamford, Connecticut, 06904, United States
Sutter Health Medical Center

Sacramento, California, 95816, United States
The Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States
The Cardiac and Vascular Institute

Gainesville, Florida, 32605, United States
The Essex Cardiothoracic Centre - Basildon & Thurrock University Hospitals

Basildon, United Kingdom
The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States
University Clinic Dusseldorf

Düsseldorf, 40225, Germany
University Clinic Erlangen

Erlangen, 91054, Germany
University Clinic of Saarland

Homburg, 66421, Germany
University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States
University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands
University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States
University of North Carolina at Chapel Hill School of Medicine

Chapel Hill, North Carolina, 27599-7075, United States
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
University of Utah

Salt Lake City, Utah, 84112, United States
Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH

Freiburg im Breisgau, D-91054, Germany
Vanderbilt University

Nashville, Tennessee, 37232, United States

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