A Study of the ReCor Medical Paradise System in Clinical Hypertension
NCT ID: NCT02649426
Last Updated: 2024-06-28
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
282 participants
INTERVENTIONAL
2016-03-31
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ultrasound Renal Denervation
Subjects in the TRIO or SOLO cohorts that are randomized to treatment, will receive renal denervation following a renal angiogram
The Paradise® Renal Denervation Ultrasound System
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 Procedure
For subjects in TRIO or SOLO cohorts that randomize to the sham procedure, the diagnostic renal angiogram intervention will be considered the sham procedure.
Sham Procedure
Randomization will occur following the diagnostic renal angiogram. For blinded patients randomized to control, the diagnostic renal angiogram will be considered the sham procedure.
Interventions
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The Paradise® Renal Denervation Ultrasound System
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 Procedure
Randomization will occur following the diagnostic renal angiogram. For blinded patients randomized to control, the diagnostic renal angiogram will be considered the sham procedure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
* 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)
18 Years
75 Years
ALL
No
Sponsors
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ReCor Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michel Azizi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Européen Georges-Pompidou
Ajay J Kirtane, M.D
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Sutter Health Medical Center
Sacramento, California, United States
Stamford Hospital
Stamford, Connecticut, United States
The Cardiac and Vascular Institute
Gainesville, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Southern Illinois University Medicine
Springfield, Illinois, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
Ochsner Heart and Vascular Insitute
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
The Brigham and Women's Hospital
Boston, Massachusetts, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Renown Institute for Heart& Vascular Health
Reno, Nevada, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
New York University School of Medicine
New York, New York, United States
Columbia University / NewYork Presbyterian Hospital
New York, New York, United States
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Cliniques Universitaires St Luc
Brussels, , Belgium
Hôpital Saint-André - CHU Bordeaux
Bordeaux, , France
CHRU Lille - Institut Coeur Poumon
Lille, , France
Hôpital de la Croix Rousse
Lyon, , France
Hôpital Européen Georges-Pompidou
Paris, , France
Clinique Pasteur
Toulouse, , France
University Clinic Dusseldorf
Düsseldorf, , Germany
University Clinic Erlangen
Erlangen, , Germany
Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH
Freiburg im Breisgau, , Germany
University Clinic of Saarland
Homburg, , Germany
Leipzig Heart Center
Leipzig, , Germany
Sana Kliniken Lübeck GmbH
Lübeck, , Germany
Katholisches Klinikum Mainz
Mainz, , Germany
Maastricht University Hospital
Maastricht, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Medical University of Gdansk
Gdansk, , Poland
Institute of Cardiology
Warsaw, , Poland
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom
Imperial College London, Hammersmith Hospital
London, England, United Kingdom
The Essex Cardiothoracic Centre - Basildon & Thurrock University Hospitals
Basildon, , United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, , United Kingdom
Conquest Hospital - Hastings
Hastings, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLN 0777
Identifier Type: -
Identifier Source: org_study_id
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