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A Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN)

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ClinicalTrials.gov Identifier: NCT02649426
Recruitment Status : Recruiting
First Posted : January 7, 2016
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
ReCor Medical, Inc.

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.

Condition or disease Intervention/treatment Phase
Hypertension Vascular Diseases Device: The Paradise® Renal Denervation Ultrasound System Device: Sham Procedure Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The "RADIANCE-HTN" Study. A Study of the ReCor Medical Paradise System in Clinical Hypertension
Study Start Date : March 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ultrasound Renal Denervation
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
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.
Other Name: renal denervation

Sham Comparator: 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.
Device: 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 Name: renal angiogram




Primary Outcome Measures :
  1. Mean reduction in average daytime ambulatory systolic BP [ Time Frame: from baseline to 2 months post procedure ]

Secondary Outcome Measures :
  1. Reduction in average 24-hr/night-time ambulatory systolic BP [ Time Frame: from baseline to 2 months post procedure ]
  2. Reduction in average daytime/24-hr/night-time diastolic BP [ Time Frame: from baseline to 2 months post procedure ]
  3. All-cause mortality [ Time Frame: from baseline to 36 months post-procedure ]
  4. Hypertensive or hypotensive emergency resulting in hospitalization [ Time Frame: up to 36 months ]
  5. Hospitalization for heart failure [ Time Frame: from baseline to 36 months post-procedure ]
  6. Stroke, transient ischemic attack, cerebrovascular accident [ Time Frame: from baseline to 36 months post-procedure ]
  7. Acute myocardial infarction [ Time Frame: from baseline to 36 months post-procedure ]
  8. End stage renal disease [ Time Frame: from baseline to 36 months post-procedure ]
  9. Renal artery or vascular complications requiring intervention [ Time Frame: from baseline to 36 months post-procedure ]
  10. Significant embolic events resulting in end organ damage [ Time Frame: from baseline to 1 month and 36 months post-procedure ]
  11. Procedure related pain lasting > 2 days [ Time Frame: from baseline to 1 month and 36 months post-procedure ]
  12. Acute renal injury [ Time Frame: from baseline to 1 month and 36 months post-procedure ]
  13. Significant (>50%) and severe (>75%) new onset renal stenosis [ Time Frame: from baseline to 6, 12, 24 and 36 months post-procedure ]
    as diagnosed by duplex ultrasound and confirmed by renal CTA/MRA or as diagnosed/confirmed by study defined renal CTA/MRA at 12 months

  14. Major access site complications [ Time Frame: from baseline to 1 month and 36 months post-procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 < 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 ≥2 mm <4 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 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) within 3 months prior to consent
  • Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV) within 3 months prior to consent
  • 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
  • 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 (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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649426


Contacts
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Contact: Helen Reeve-Stoffer, PhD +44 7947 748006 hreeve-stoffer@recormedical.com
Contact: Meital Horesh-Bar, BA +1 650 542-9785 mhoresh-bar@recormedical.com

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Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Michele Blue, RN    205-975-4338    mblue@uabmc.edu   
Principal Investigator: David Calhoun, MD         
Sub-Investigator: Tom McElderry, MD         
Sub-Investigator: William Maddox, MD         
United States, California
Kaiser Permanente Withdrawn
Los Angeles, California, United States, 90027
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90211
Contact: Mohammad Rashid    424-315-2501    Mohamad.Rashid@cshs.org   
Contact: Kirin Bhatia, BA    (310) 248-8245    Kirin.bhatia@cshs.org   
Principal Investigator: Florian Radar         
Sutter Health Medical Center Active, not recruiting
Sacramento, California, United States, 95816
Stanford Hospital Withdrawn
Stanford, California, United States, 94305
United States, Connecticut
Stamford Hospital Recruiting
Stamford, Connecticut, United States, 06904
Contact: Juan Garcia    203-276-7880    jgarcia1@stamhealth.org   
Principal Investigator: David Hsi, MD         
United States, Florida
The Cardiac and Vascular Institute Recruiting
Gainesville, Florida, United States, 32605
Contact: Alice Boyette    352-244-0208    aboyette@tcavi.com   
Principal Investigator: Matheen Khuddus, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30308
Contact: Amanda Fiebach    404-686-7468    amanda.fiebach@emoryhealthcare.org   
Principal Investigator: Chandan Devireddy         
United States, Illinois
Southern Illinois University Medicine Recruiting
Springfield, Illinois, United States, 62794
Contact: Lori Miedwig    217-545-4402    lmiedwig@siumed.edu   
Principal Investigator: John Flack, MD         
United States, Indiana
Franciscan Health Indianapolis Recruiting
Indianapolis, Indiana, United States
Contact: Timothy Brown       timothy.brown@franciscanalliance.org   
Principal Investigator: Atul Chugh, MD         
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Jeannine Chapman    859-260-6172    jeannie.chapman@bhsi.com   
Principal Investigator: Michael Jones, MD         
United States, Louisiana
Ochsner Heart and Vascular Insitute Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Cristine Hardy    504-842-6832    chardy@ochsner.org   
Contact: Maria Jarvis    504-842-8093    maria.jarvis@ochsner.org   
Sub-Investigator: Richard Re, MD         
Sub-Investigator: Tyrone Collins, MD         
Sub-Investigator: Rajan Patel, MD         
Principal Investigator: James S Jenkins, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Diana Yang    617-643-1372    dyang12@bwh.harvard.edu   
Sub-Investigator: Doug Drachman, MD         
Sub-Investigator: Randall Zusman, MD         
Principal Investigator: Joseph Garasic, MD         
The Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02120
Contact: Leah Schroeder    617-732-7381    lvsschroeder@bwh.harvard.edu   
Principal Investigator: Naomi Fisher, MD         
United States, Minnesota
Minneapolis Heart Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Rose Peterson, RN, BA, LNC, CCRP    612-863-6051    rose.peterson@allina.com   
Principal Investigator: Yale L Wang, MD         
Sub-Investigator: Robert Schwartz, MD         
United States, Nevada
Renown Institute for Heart& Vascular Health Recruiting
Reno, Nevada, United States, 89502
Contact: Priscilla Nelson    775-982-2217    pnelson@renown.org   
Contact: Bridget Neumann       BNeumann@renown.org   
Principal Investigator: Michael Bloch         
United States, New Jersey
Deborah Heart and Lung Center Recruiting
Browns Mills, New Jersey, United States, 08015
Contact: Luot Lewis, RN    609-893-1200 ext 5022    LewisL@Deborah.org   
Principal Investigator: Kintur Sanghvi, MD         
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10010
Contact: Stanley Cobos    646-501-2897    Stanley.Cobos@nyumc.org   
Principal Investigator: Sripal Bangalore         
Columbia University / NewYork Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Candido Batres, MD    212-342-3486    cb2269@cumc.columbia.edu   
Principal Investigator: Ajay Kirtane, MD         
United States, North Carolina
University of North Carolina at Chapel Hill School of Medicine Recruiting
Chapel Hill, North Carolina, United States, 27599-7075
Contact: Tyrone Wade    919-962-4896    tyrone_wade@med.unc.edu   
Principal Investigator: George Stouffer         
United States, Ohio
University Hospitals Cleveland Medical Center Active, not recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Withdrawn
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Nancy Katof    215-762-3369    nsk39@drexel.edu   
Principal Investigator: Jessie Goldman         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Robin Neubauer    216-615-0773    Robin.Neubauer@uphs.upenn.edu   
Principal Investigator: Debbie Cohen, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29403
Contact: Vijay Paladugu    843-876-5009    paladugc@musc.edu   
Principal Investigator: Tom Todoran, MD         
Sub-Investigator: Jan Basile, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sarita Madell    615-343-9071    Sarita.m.madell@vanderbilt.edu   
Principal Investigator: Pete Fong, MD         
United States, Texas
The Heart Hospital Baylor Plano Active, not recruiting
Plano, Texas, United States, 75093
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Sarah Neagle    801-585-1897    sarah.neagle@hsc.utah.edu   
Contact: Jenice Herrera    801-581-6177    jenice.herrera@hsc.utah.edu   
Principal Investigator: Josephine Abraham, MD         
Belgium
Cliniques Universitaires St Luc Recruiting
Brussels, Belgium, 1200
Contact: Alexandre Persu, MD, PhD       alexandre.persu@uclouvain.be   
Principal Investigator: Alexandre Persu, MD, PhD         
France
Hôpital Saint-André - CHU Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Philippe Gosse, MD       philippe.gosse@chu-bordeaux.fr   
Principal Investigator: Philippe Gosse, MD         
Hôpital de la Croix Rousse Recruiting
Lyon, France, 69004
Contact: Pierre Lantelme, MD, PhD       pierre.lantelme@chu-lyon.fr   
Principal Investigator: Pierre Lantelme, MD, PhD         
Hôpital Européen Georges-Pompidou Recruiting
Paris, France, 75015
Contact: Michel Azizi, MD, PhD       michel.azizi@aphp.fr   
Principal Investigator: Michel Azizi, MD, PhD         
Sub-Investigator: Marc Sapoval, MD, PhD         
CHU Rennes, Hôpital Pontchaillou Withdrawn
Rennes, France, 35033
Clinique Pasteur Recruiting
Toulouse, France, 31300
Contact: Athul Pathak, MD, PhD       apathak@clinique-pasteur.com   
Principal Investigator: Athul Pathak, MD, PhD         
Germany
University Clinic Dusseldorf Recruiting
Dusseldorf, Germany, 40225
Contact: Lars C Rump, MD, PhD       Christian.Rump@med.uni-duesseldorf.de   
Principal Investigator: Lars C Rump, MD, PhD         
University Clinic Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Roland Schmieder, MD, PhD       roland.schmieder@uk-erlangen.de   
Principal Investigator: Roland Schmieder, MD, PhD         
University Medical Center Goettingen Withdrawn
Goettingen, Germany, 37075
Medizinische Hochschule Hannover Withdrawn
Hannover, Germany, 30625
University Clinic of Saarland Recruiting
Homburg, Germany, 66421
Contact: Felix Mahfoud, MD       Felix.Mahfoud@uniklinikum-saarland.de   
Principal Investigator: Felix Mahfoud, MD         
Leipzig Heart Center Recruiting
Leipzig, Germany, 04289
Contact: Philipp Lurz, MD, PhD       philipp.lurz@medizin.uni-leipzig.de   
Principal Investigator: Philipp Lurz, MD, PhD         
Sana Kliniken Lübeck GmbH Recruiting
Lübeck, Germany, 23560
Contact: Joachim Weil, MD, PhD       Joachim.Weil@Sana.de   
Principal Investigator: Joachim Weil, MD, PhD         
Katholisches Klinikum Mainz Recruiting
Mainz, Germany, 55131
Contact: Sabine Genth-Zotz, MD       s-genth-zotz@kkmainz.de   
Principal Investigator: Sabine Genth-Zotz, MD         
Sub-Investigator: Denise Kämpfner, MD         
Sub-Investigator: Armin Grawe, MD         
Sub-Investigator: Johannes Höhne, MD         
Sub-Investigator: Andreas Liebrich, MD         
Netherlands
Maastricht University Hospital Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Abraham A Kroon, MD, PhD       aa.kroon@mumc.nl   
Principal Investigator: Abraham A Kroon, MD, Phd         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Arno H Ruiter       a.ruiter@erasmusmc.nl   
Principal Investigator: Joost Daemen, MD, PhD         
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Peter J Blankestijn, MD       P.J.Blankestijn@umcutrecht.nl   
Principal Investigator: Peter J Blankestijn, MD         
Poland
Medical University of Gdansk Recruiting
Gdańsk, Poland, 80-952
Contact: Dagmara Hering, MD       hering@gumed.edu.pl   
Principal Investigator: Dagmara Hering, MD         
Sub-Investigator: Jakub Sobolewski, MD         
Sub-Investigator: Jaroslaw Jaguszewski, MD         
Institute of Cardiology Recruiting
Warsaw, Poland, 04-628
Contact: Adam Witkowski, MD, PhD       witkowski@hbz.pl   
Principal Investigator: Adam Witkowski, MD, PhD         
United Kingdom
Royal Bournemouth Hospital Recruiting
Bournemouth, England, United Kingdom, BH7 7DW
Contact       cardiac.research@rbch.nhs.uk   
Principal Investigator: Terry Levy, MD         
Sub-Investigator: David Beckett, MD         
Sub-Investigator: Clare Bent, MD         
Sub-Investigator: Richard Bala, MD         
Sub-Investigator: Amit Patel, MD         
Imperial College London, Hammersmith Hospital Active, not recruiting
London, England, United Kingdom, SW7 2AZ
The Essex Cardiothoracic Centre - Basildon & Thurrock University Hospitals Recruiting
Basildon, United Kingdom
Contact: Research Team    0044 (0)1268 524900    BloodPressureStudy@btuh.nhs.uk   
Principal Investigator: Jeremy Sayer, MD         
Sub-Investigator: Sudha Iyer, MD         
Sub-Investigator: Nicholas Robinson, MD         
Sub-Investigator: Thomas Keeble, MD         
Conquest Hospital - Hastings Recruiting
East Sussex, United Kingdom, TN37 7RD
Contact: Robert Gerber, MD       r.gerber@nhs.net   
Principal Investigator: Robert Gerber, MD         
Royal Devon and Exeter Hospital (Wonford) Recruiting
Exeter, United Kingdom, EX2 5DW
Contact: Andrew Sharp, MD       andrew.sharp5@nhs.net   
Contact: Christine Anning       c.anning@nhs.net   
Principal Investigator: Andrew Sharp, MD         
Sub-Investigator: Hibba Kurdi, MD         
Sub-Investigator: Richard J. D'Souza, MD         
Sub-Investigator: Uwadiegwu W. Okoroafor, MD         
Sub-Investigator: Anthony Watkinson, MD, PhD         
St Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Contact: Manish Saxena, MD       m.saxena@qmul.ac.uk   
Principal Investigator: Melvin Lobo, MD         
Sub-Investigator: Manish Saxena, MD         
Sub-Investigator: David J. Collier, MD         
Sub-Investigator: Ajay K. Jain, MD         
Sub-Investigator: Mathur Anthony, MD         
Sponsors and Collaborators
ReCor Medical, Inc.
Investigators
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Principal Investigator: Michel Azizi, MD, PhD Hôpital Européen Georges-Pompidou
Principal Investigator: Ajay J Kirtane, M.D Columbia University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ReCor Medical, Inc.
ClinicalTrials.gov Identifier: NCT02649426     History of Changes
Other Study ID Numbers: CLN 0777
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: to be determined
Keywords provided by ReCor Medical, Inc.:
denervation
resistant hypertension
essential hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases