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HypertensionRADIANCE-HTNNCT02649426

A Study of the ReCor Medical Paradise System in Clinical Hypertension

A study testing The Paradise® Renal Denervation Ultrasound System in people with Hypertension and Vascular Diseases, run by ReCor Medical, Inc. at 49 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypertension, Vascular Diseases
What is being tested?
The Paradise® Renal Denervation Ultrasound System
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
282 participants
Where
49 sitesin 7 countries
Study dates
Mar 2016to May 2027
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

49 sites in 7 countries.

49 sites in 7 countries

United States24 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • The Brigham and Women's Hospital

    Boston, Massachusetts, 02120

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • University of North Carolina at Chapel Hill School of Medicine

    Chapel Hill, North Carolina, 27599-7075

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Cardiac and Vascular Institute

    Gainesville, Florida, 32605

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90211

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Ochsner Heart and Vascular Insitute

    New Orleans, Louisiana, 70121

  • New York University School of Medicine

    New York, New York, 10010

  • Columbia University / NewYork Presbyterian Hospital

    New York, New York, 10032

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • Renown Institute for Heart& Vascular Health

    Reno, Nevada, 89502

  • Sutter Health Medical Center

    Sacramento, California, 95816

  • University of Utah

    Salt Lake City, Utah, 84112

  • Southern Illinois University Medicine

    Springfield, Illinois, 62794

  • Stamford Hospital

    Stamford, Connecticut, 06904

Other trials in United States

Germany7 sites

  • University Clinic Dusseldorf

    Düsseldorf, 40225

  • University Clinic Erlangen

    Erlangen, 91054

  • Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH

    Freiburg im Breisgau, D-91054

  • University Clinic of Saarland

    Homburg, 66421

  • Leipzig Heart Center

    Leipzig, 04289

  • Sana Kliniken Lübeck GmbH

    Lübeck, 23560

  • Katholisches Klinikum Mainz

    Mainz, 55131

Other trials in Germany

United Kingdom7 sites

  • The Essex Cardiothoracic Centre - Basildon & Thurrock University Hospitals

    Basildon

  • Royal Bournemouth Hospital

    Bournemouth, England, BH7 7DW

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, EX2 5DW

  • Conquest Hospital - Hastings

    Hastings, TN37 7RD

  • Imperial College London, Hammersmith Hospital

    London, England, SW7 2AZ

  • St Bartholomew's Hospital

    London, EC1A 7BE

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

Other trials in United Kingdom

France5 sites

  • Hôpital Saint-André - CHU Bordeaux

    Bordeaux, 33000

  • CHRU Lille - Institut Coeur Poumon

    Lille, 59000

  • Hôpital de la Croix Rousse

    Lyon, 69004

  • Hôpital Européen Georges-Pompidou

    Paris, 75015

  • Clinique Pasteur

    Toulouse, 31300

Other trials in France

Netherlands3 sites

  • Maastricht University Hospital

    Maastricht, 6229 HX

  • Erasmus Medical Center

    Rotterdam, 3015 CE

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Poland2 sites

  • Medical University of Gdansk

    Gdansk, 80-952

  • Institute of Cardiology

    Warsaw, 04-628

Other trials in Poland

Belgium1 site

  • Cliniques Universitaires St Luc

    Brussels, 1200

Other trials in Belgium

About this study

Official title: The "RADIANCE-HTN" Study. A Study of the ReCor Medical Paradise System in Clinical Hypertension

RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.

Read the detailed description

Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort while subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications will be included in the RADIANCE Trio cohort. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication (SOLO) or despite the presence of a stabilized, single pill, triple, fixed dose antihypertensive medication regimen (TRIO).

Being tested
The Paradise® Renal Denervation Ultrasound System, Sham Procedure
Keywords
denervation, resistant hypertension, essential hypertension
Medical subject headings
Hypertension, Vascular Diseases, Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Paradise® Renal Denervation Ultrasound SystemDevice

    Also called renal denervation

    Randomization will occur following the diagnostic renal angiogram. Blinded patients randomized to treatment will receive the renal denervation procedure using the Paradise System to deliver ultrasound energy to thermally ablate and disrupt the renal sympathetic nerves while sparing the renal arterial wall.

  • Sham ProcedureDevice

    Also called renal angiogram

    Randomization will occur following the diagnostic renal angiogram. For blinded patients randomized to control, the diagnostic renal angiogram will be considered the sham procedure.

Study groups in NCT02649426
Study groupRoleWhat they receive
Ultrasound Renal DenervationExperimentalSubjects in the TRIO or SOLO cohorts that are randomized to treatment, will receive renal denervation following a renal angiogram
Receives: Device: The Paradise® Renal Denervation Ultrasound System
Sham ProcedureSham comparatorFor subjects in TRIO or SOLO cohorts that randomize to the sham procedure, the diagnostic renal angiogram intervention will be considered the sham procedure.
Receives: Device: Sham Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Solo Cohort - Mean Difference in Average Daytime Ambulatory Systolic BP

    Mean difference in average daytime ambulatory systolic BP of the Solo cohort

    Measured: from baseline to 2 months post procedure

  2. Trio Cohort - Median Change in Daytime Ambulatory Systolic BP

    Median change in daytime ambulatory systolic BP of the Trio cohort

    Measured: from baseline to 2 months post procedure

Secondary outcomes (14)

  1. Reduction in Average 24-hr/Night-time Ambulatory Systolic BP

    Measured: from baseline to 2 months post procedure

  2. Reduction in Average Daytime/24-hr/Night-time Diastolic BP

    Measured: from baseline to 2 months post procedure

  3. All-cause Mortality

    Measured: from baseline to 36 months post-procedure

  4. Hypertensive or Hypotensive Emergency Resulting in Hospitalization

    Measured: up to 36 months

  5. Hospitalization for Heart Failure

    Measured: from baseline to 36 months post-procedure

  6. Stroke, Transient Ischemic Attack, Cerebrovascular Accident

    Measured: from baseline to 36 months post-procedure

  7. Acute Myocardial Infarction

    Measured: from baseline to 36 months post-procedure

  8. End Stage Renal Disease

    Measured: from baseline to 36 months post-procedure

  9. Renal Artery or Vascular Complications Requiring Intervention

    Measured: from baseline to 36 months post-procedure

  10. Significant Embolic Events Resulting in End Organ Damage

    Measured: from baseline to 1 month and 36 months post-procedure

  11. Procedure Related Pain Lasting > 2 Days

    Measured: from baseline to 1 month and 36 months post-procedure

  12. Acute Renal Injury

    Measured: from baseline to 1 month and 36 months post-procedure

  13. Significant (>50%) and Severe (>75%) New Onset Renal Stenosis

    as diagnosed by duplex ultrasound and confirmed by renal CTA/MRA or as diagnosed/confirmed by study defined renal CTA/MRA at 12 months

    Measured: from baseline to 6, 12, 24 and 36 months post-procedure

  14. Major Access Site Complications

    Measured: from baseline to 1 month and 36 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionSep 2020
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02649426
Sponsor's protocol ID
CLN 0777
Acronym
RADIANCE-HTN
Status last verified
Mar 2026
First submitted
4 Jan 2016
Last updated
21 Apr 2026
Data monitoring committee
Yes
Individual data sharing
Undecided: to be determined

Publications

  • Bytyqi V, Kannenkeril D, Striepe K, Bosch A, Karg MV, Schmid A, Schiffer M, Uder M, Schmieder RE. Predicting blood pressure response to renal denervation based on a new approach. J Hypertens. 2025 Mar 1;43(3):413-419. doi: 10.1097/HJH.0000000000003918. Epub 2024 Oct 29.

    PubMed 39526682

  • Azizi M, Sharp ASP, Fisher NDL, Weber MA, Lobo MD, Daemen J, Lurz P, Mahfoud F, Schmieder RE, Basile J, Bloch MJ, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Claude L, Augustin DA, McClure CK, Kirtane AJ; RADIANCE Investigators. Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program. Circulation. 2024 Mar 5;149(10):747-759. doi: 10.1161/CIRCULATIONAHA.123.066941. Epub 2023 Oct 26.

    PubMed 37883784

  • Kirtane AJ, Sharp ASP, Mahfoud F, Fisher NDL, Schmieder RE, Daemen J, Lobo MD, Lurz P, Basile J, Bloch MJ, Weber MA, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Sapoval M, Barman NC, Claude L, Augustin D, Thackeray L, Mullin CM, Azizi M; RADIANCE Investigators and Collaborators. Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials. JAMA Cardiol. 2023 May 1;8(5):464-473. doi: 10.1001/jamacardio.2023.0338.

    PubMed 36853627

  • Azizi M, Mahfoud F, Weber MA, Sharp ASP, Schmieder RE, Lurz P, Lobo MD, Fisher NDL, Daemen J, Bloch MJ, Basile J, Sanghvi K, Saxena M, Gosse P, Jenkins JS, Levy T, Persu A, Kably B, Claude L, Reeve-Stoffer H, McClure C, Kirtane AJ; RADIANCE-HTN Investigators. Effects of Renal Denervation vs Sham in Resistant Hypertension After Medication Escalation: Prespecified Analysis at 6 Months of the RADIANCE-HTN TRIO Randomized Clinical Trial. JAMA Cardiol. 2022 Dec 1;7(12):1244-1252. doi: 10.1001/jamacardio.2022.3904.

    PubMed 36350593

  • Sanghvi K, Wang Y, Daemen J, Mathur A, Jain A, Dohad S, Sapoval M, Azizi M, Mahfoud F, Lurz P, Sayer J, Levy T, Zagoria R, Loening AM, Coleman L, Craig D, Horesh-Bar M, Kirtane AJ. Renal Artery Variations in Patients With Mild-to-Moderate Hypertension From the RADIANCE-HTN SOLO Trial. Cardiovasc Revasc Med. 2022 Jun;39:58-65. doi: 10.1016/j.carrev.2021.09.008. Epub 2021 Sep 30.

    PubMed 34620570

  • Fisher NDL, Kirtane AJ, Daemen J, Rader F, Lobo MD, Saxena M, Abraham J, Schmieder RE, Sharp ASP, Gosse P, Claude L, Song Y, Azizi M; RADIANCE-HTN Investigators. Plasma renin and aldosterone concentrations related to endovascular ultrasound renal denervation in the RADIANCE-HTN SOLO trial. J Hypertens. 2022 Feb 1;40(2):221-228. doi: 10.1097/HJH.0000000000002994.

    PubMed 34433763

  • Azizi M, Sanghvi K, Saxena M, Gosse P, Reilly JP, Levy T, Rump LC, Persu A, Basile J, Bloch MJ, Daemen J, Lobo MD, Mahfoud F, Schmieder RE, Sharp ASP, Weber MA, Sapoval M, Fong P, Pathak A, Lantelme P, Hsi D, Bangalore S, Witkowski A, Weil J, Kably B, Barman NC, Reeve-Stoffer H, Coleman L, McClure CK, Kirtane AJ; RADIANCE-HTN investigators. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet. 2021 Jun 26;397(10293):2476-2486. doi: 10.1016/S0140-6736(21)00788-1. Epub 2021 May 16.

    PubMed 34010611

  • Gosse P, Cremer A, Kirtane AJ, Lobo MD, Saxena M, Daemen J, Wang Y, Stegbauer J, Weber MA, Abraham J, Kario K, Bangalore S, Claude L, Liu Y, Azizi M. Ambulatory Blood Pressure Monitoring to Predict Response to Renal Denervation: A Post Hoc Analysis of the RADIANCE-HTN SOLO Study. Hypertension. 2021 Feb;77(2):529-536. doi: 10.1161/HYPERTENSIONAHA.120.16292. Epub 2020 Dec 28.

    PubMed 33356403

  • Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Lobo MD, Sharp ASP, Bloch MJ, Basile J, Wang Y, Saxena M, Lurz P, Rader F, Sayer J, Fisher NDL, Fouassier D, Barman NC, Reeve-Stoffer H, McClure C, Kirtane AJ; RADIANCE-HTN Investigators. Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control After Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial. Circulation. 2019 May 28;139(22):2542-2553. doi: 10.1161/CIRCULATIONAHA.119.040451. Epub 2019 Mar 17.

    PubMed 30880441

  • Calhoun DA, Schiffrin EL, Flack JM. Resistant Hypertension: An Update. Am J Hypertens. 2019 Jan 1;32(1):1-3. doi: 10.1093/ajh/hpy156. No abstract available.

    PubMed 30407514

  • Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Davies J, Basile J, Kirtane AJ, Wang Y, Lobo MD, Saxena M, Feyz L, Rader F, Lurz P, Sayer J, Sapoval M, Levy T, Sanghvi K, Abraham J, Sharp ASP, Fisher NDL, Bloch MJ, Reeve-Stoffer H, Coleman L, Mullin C, Mauri L; RADIANCE-HTN Investigators. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345. doi: 10.1016/S0140-6736(18)31082-1. Epub 2018 May 23.

    PubMed 29803590

Questions about this trial

What is this clinical trial studying?

A study testing The Paradise® Renal Denervation Ultrasound System in people with Hypertension and Vascular Diseases, run by ReCor Medical, Inc. at 49 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Germany, United Kingdom, France, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Solo Cohort - Mean Difference in Average Daytime Ambulatory Systolic BP (time frame: from baseline to 2 months post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02649426, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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