A Study of the ReCor Medical Paradise System in Clinical Hypertension

NCT02649426 | Active Not Recruiting Results DMC

• 1 other identifier: CLN 0777
• Study Type: interventional
• Target: 282
• Locations: 7 countries
• Sites: 49

Brief 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.

Conditions

Hypertension; Vascular Diseases

Keywords

denervation; resistant hypertension; essential hypertension

Outcome Measures

Primary Outcomes (2)

• Solo Cohort - Mean Difference in Average Daytime Ambulatory Systolic BP

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

  from baseline to 2 months post procedure

• Trio Cohort - Median Change in Daytime Ambulatory Systolic BP

  Median change in daytime ambulatory systolic BP of the Trio cohort

  from baseline to 2 months post procedure

Secondary Outcomes (14)

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

  from baseline to 2 months post procedure

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

  from baseline to 2 months post procedure

• All-cause Mortality

  from baseline to 36 months post-procedure

• Hypertensive or Hypotensive Emergency Resulting in Hospitalization

  up to 36 months

• Hospitalization for Heart Failure

  from baseline to 36 months post-procedure

Study Arms (2)

Ultrasound Renal Denervation

EXPERIMENTAL

Subjects in the TRIO or SOLO cohorts that are randomized to treatment, will receive renal denervation following a renal angiogram

Device: The Paradise® Renal Denervation Ultrasound System

Sham Procedure

SHAM COMPARATOR

For subjects in TRIO or SOLO cohorts that randomize to the sham procedure, the diagnostic renal angiogram intervention will be considered the sham procedure.

Device: Sham Procedure

Interventions

The Paradise® Renal Denervation Ultrasound System DEVICE

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.

Also known as: renal denervation

Ultrasound Renal Denervation

Sham Procedure DEVICE

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

Also known as: renal angiogram

Sham Procedure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ReCor Medical, Inc.: lead

Study Sites (49)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90211, United States

Location

Sutter Health Medical Center

Sacramento, California, 95816, United States

Location

Stamford Hospital

Stamford, Connecticut, 06904, United States

Location

The Cardiac and Vascular Institute

Gainesville, Florida, 32605, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Southern Illinois University Medicine

Springfield, Illinois, 62794, United States

Location

Franciscan Health Indianapolis

Indianapolis, Indiana, 46237, United States

Location

Ochsner Heart and Vascular Insitute

New Orleans, Louisiana, 70121, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

The Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Renown Institute for Heart& Vascular Health

Reno, Nevada, 89502, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

New York University School of Medicine

New York, New York, 10010, United States

Location

Columbia University / NewYork Presbyterian Hospital

New York, New York, 10032, United States

Location

University of North Carolina at Chapel Hill School of Medicine

Chapel Hill, North Carolina, 27599-7075, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

Hôpital Saint-André - CHU Bordeaux

Bordeaux, 33000, France

Location

CHRU Lille - Institut Coeur Poumon

Lille, 59000, France

Location

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Hôpital Européen Georges-Pompidou

Paris, 75015, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

University Clinic Dusseldorf

Düsseldorf, 40225, Germany

Location

University Clinic Erlangen

Erlangen, 91054, Germany

Location

Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH

Freiburg im Breisgau, D-91054, Germany

Location

University Clinic of Saarland

Homburg, 66421, Germany

Location

Leipzig Heart Center

Leipzig, 04289, Germany

Location

Sana Kliniken Lübeck GmbH

Lübeck, 23560, Germany

Location

Katholisches Klinikum Mainz

Mainz, 55131, Germany

Location

Maastricht University Hospital

Maastricht, 6229 HX, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3015 CE, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Medical University of Gdansk

Gdansk, 80-952, Poland

Location

Institute of Cardiology

Warsaw, 04-628, Poland

Location

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

Location

Imperial College London, Hammersmith Hospital

London, England, SW7 2AZ, United Kingdom

Location

The Essex Cardiothoracic Centre - Basildon & Thurrock University Hospitals

Basildon, United Kingdom

Location

Royal Devon and Exeter Hospital (Wonford)

Exeter, EX2 5DW, United Kingdom

Location

Conquest Hospital - Hastings

Hastings, TN37 7RD, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 37883784 DERIVED

• 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.

  PMID: 36853627 DERIVED

• 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.

  PMID: 36350593 DERIVED

• 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.

  PMID: 34620570 DERIVED

• 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.

  PMID: 34433763 DERIVED

• 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.

  PMID: 34010611 DERIVED

• 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.

  PMID: 33356403 DERIVED

• 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.

  PMID: 30880441 DERIVED

• 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.

  PMID: 30407514 DERIVED

• 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.

  PMID: 29803590 DERIVED

MeSH Terms

Conditions

Hypertension; Vascular Diseases; Essential Hypertension

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Results Point of Contact

• Title: Chief Clinical Officer
• Organization: ReCor Medical Inc.

hreeve-stoffer@recormedical.com

+1-650-420-8048

Study Officials

• Michel Azizi, MD, PhD

  Hôpital Européen Georges-Pompidou

  PRINCIPAL INVESTIGATOR

• Ajay J Kirtane, M.D

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 7, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2020
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 21, 2026
• Results First Posted: June 28, 2024

Record last verified: 2026-03

Locations

GB (7); FR (5); NL (3); PL (2); DE (7); US (24); BE (1)