Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)
This study is currently recruiting participants.
Verified May 2013 by Medtronic Vascular
Sponsor:
Medtronic Vascular
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01418261
First received: August 15, 2011
Last updated: May 2, 2013
Last verified: May 2013
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Purpose
The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.
| Condition | Intervention | Phase |
|---|---|---|
|
Uncontrolled Hypertension |
Device: Renal denervation (Symplicity Catheter System) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Medtronic Vascular:
Primary Outcome Measures:
- Change in Office Systolic Blood Pressure [ Time Frame: Baseline to 6 months post-randomization ] [ Designated as safety issue: No ]Primary Effectiveness Outcome Measure
- Incidence of Major Adverse Events through 1 month post-randomization (Renal artery stenosis measured at 6 months) [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 530 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Renal Denervation
Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications
|
Device: Renal denervation (Symplicity Catheter System)
Symplicity Catheter System
|
|
No Intervention: Control group
Subjects are maintained on baseline anti-hypertensive medications
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Individual is ≥ 18 and ≤ 80 years old at time of randomization.
- Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 2 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.
- Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit
Exclusion Criteria:
- Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
- Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP < 135 mmHg
- Individual has type 1 diabetes mellitus
- Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
- Individual has primary pulmonary hypertension.
- Individual is pregnant, nursing or planning to be pregnant.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418261
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Contacts
| Contact: V. DeBruin | RS.CT-GovInquiry@medtronic.com |
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| United States, Alabama | |
| Cardiology, PC | Recruiting |
| Birmingham, Alabama, United States, 35211 | |
| Contact: Susan DeRamus 205-780-4330 ext 338 sderamus@cardiologypc.com | |
| Principal Investigator: Farrell Mendelsohn, MD | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Eric Judd 205-960-4594 ejudd@uab.edu | |
| Principal Investigator: David Calhoun | |
| United States, California | |
| Scripps Clinic/Scripps Green Hospital | Recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: Chelsea Butler, RN 858-554-5374 butler.chelsea@scrippshealth.org | |
| Principal Investigator: Andrew King, MD | |
| Principal Investigator: Paul Teirstein, MD | |
| Cedars Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Virginia Leonte 310-423-3992 Virginia.Leonte@cshs.org | |
| Principal Investigator: Florian Rader, MD | |
| Principal Investigator: Raj Makkar, MD | |
| Kaiser Permanente - Los Angeles Medical Center | Recruiting |
| Los Angeles, California, United States, 90027 | |
| St. Joseph Hospital | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Gemma Miralles, RN 714-744-8776 gemma.miralles@stjoe.org | |
| Principal Investigator: Mahmood Razavi, MD | |
| San Diego Cardiac Center | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Jamie Schmitt 858-244-6825 jschmitt@sdcardiac.com | |
| Principal Investigator: Raghava Gollapudi, MD | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Maria Perlas 650-723-2094 mperlas@stanford.edu | |
| Principal Investigator: Dr David Lee | |
| United States, Colorado | |
| University of Colorado Hospital | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Christina Schmitt, RN 303-724-2098 Christina.Schmitt@ucdenver.edu | |
| Principal Investigator: Kevin Rogers, MD | |
| United States, Connecticut | |
| Pat and Jim Calhoun Cardiology Center - University of Connecticut Health Center | Recruiting |
| Farmington, Connecticut, United States, 06030-2202 | |
| Contact: Cheryl Martin, RN, BSN, CCRP (860) 679-2943 cmartin@uchc.edu | |
| Principal Investigator: Kanwar Singh, MD | |
| United States, District of Columbia | |
| MedStar Washington Hospital Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Suman Singh 202-877-8475 Suman.singh@medstar.net | |
| Principal Investigator: Ron Waksman, MD | |
| Howard University Hospital | Recruiting |
| Washington, District of Columbia, United States, 20060 | |
| Contact: Muluemebet Ketettee 202-865-3233 mketete@Howard.edu | |
| Principal Investigator: Otelio Randall, MD | |
| Sub-Investigator: Prithviraj Rai, MD | |
| George Washington University Hospital | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Contact: Lorraine Marshall, RN 202-741-2318 lmarshall@mfa.gwu.edu | |
| Principal Investigator: Jonathan Reiner, MD | |
| United States, Florida | |
| Shands / University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Sarah Long, RN 352-273-8932 Sarah.long@medicine.ufl.edu | |
| Principal Investigator: R. David Anderson, MD | |
| Mayo Clinic | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Dana Kontras, RN MSN CCRP 904-953-8939 Kontras.Dana@mayo.edu | |
| Principal Investigator: Issam Moussa, MD | |
| University Of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Ximena Marincic, RN 305-243-9200 IMInstitute@med.miami.edu | |
| Contact: Elias Querales., RN 305-243-9200 IMInstitute@med.miami.edu | |
| Principal Investigator: Eduardo De Marchena, MD | |
| Baptist Cardiac &Vascular Institute, Baptist Health Systems | Recruiting |
| Miami, Florida, United States, 33176 | |
| Contact: Alex Powell, MD 786-596-5990 AlexP@baptisthealth.net | |
| Principal Investigator: Alex Powell, MD | |
| Tampa General Hospital | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact: Courtney Lee, RN 813-353-8535 courtneyelee@tgh.org | |
| Principal Investigator: Fadi Matar, MD | |
| United States, Georgia | |
| Emory University Hospital Midtown | Recruiting |
| Atlanta, Georgia, United States, 30308 | |
| Contact: Theresa Sanders 404-686-3872 theresa.sanders@emoryhealthcare.org | |
| Principal Investigator: Chandan M Devireddy, MD | |
| Piedmont Heart Institute | Recruiting |
| Atlanta, Georgia, United States, 30309 | |
| Contact: David Kandzari, MD 404-605-5127 david.kandzari@piedmont.org | |
| Principal Investigator: David Kandzari, MD | |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Melanie Norstrom 773-702-0347 mnorstrom@medicine.bsd.uchicago.edu | |
| Principal Investigator: Dr. Sandeep Nathan | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Jade Irving 312-695-6826 jirving@nmh.org | |
| Principal Investigator: Keith Benzuly, MD | |
| Midwest Heart Foundation | Recruiting |
| Oak Brook Terrace, Illinois, United States, 60181 | |
| Contact: Lea Elder, RN, MSN, MBA 630-873-3403 lelder@midwestheart.org | |
| Principal Investigator: Mark Goodwin, MD | |
| Prairie Heart Institute | Recruiting |
| Springfield, Illinois, United States, 62701 | |
| Contact: Danielle Kolakowski 217-492-9100 ext 146 dkolakowski@prairieresearch.com | |
| Contact: Raegan Hamrick 217-492-9100 ext 120 rhamrick@prairieresearch.com | |
| Principal Investigator: Nilesh J Goswami, MD | |
| United States, Iowa | |
| Iowa Heart Center Research | Recruiting |
| Des Moines, Iowa, United States, 50266 | |
| Contact: Terri Harris, RN, BSN, MHA 515-633-3848 TKHarris@iowaheart.com | |
| Principal Investigator: Magdi Ghali | |
| United States, Kentucky | |
| University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536 | |
| Contact: Heather Shinall, RN 859-323-5259 h.shinall@uky.edu | |
| Principal Investigator: Khaled Ziada, MD | |
| United States, Louisiana | |
| Ochsner Medical Center | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| Contact: Cristine Hardy 504-842-6832 chardy@ochsner.org | |
| Principal Investigator: John.P Reilly | |
| United States, Maryland | |
| University of Maryland, Baltimore | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Joanne Marshall, RN MS 410-328-8790 jmarshal@medicine.umaryland.edu | |
| Principal Investigator: Anuj Gupta, MD | |
| United States, Massachusetts | |
| VA Boston Healthcare System | Recruiting |
| Boston, Massachusetts, United States, 02132 | |
| Contact: Sara Temiyasathit Jones, PhD 857-203-6065 sarajones8@va.gov | |
| Principal Investigator: Robert Hamburger, MD | |
| Principal Investigator: Scott Kinlay, MBBS PhD | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Jonah Zuflacht 617-732-6320 Jzuflacht@partners.org | |
| Principal Investigator: Mark Creager, MD | |
| Lahey Clinic | Recruiting |
| Burlington, Massachusetts, United States, 01805 | |
| Contact: Judy Pendleton 781-744-7512 Judy.E.Pendleton@lahey.org | |
| Principal Investigator: Dr. Sergio Waxman | |
| UMass Memorial Medical Center | Recruiting |
| Worcester, Massachusetts, United States, 01655 | |
| Contact: Noelle Bodkin, MS 508-856-1014 CardioResearch@umassmed.edu | |
| Principal Investigator: Dr. Daniel Fisher | |
| Principal Investigator: Dr. Robert Phillips | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Wendy Warshal 734-232-4277 warshal@med.umich.edu | |
| Principal Investigator: Hitinder Gurm, MD | |
| Harper University Hospital - Detroit Medical Center | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Elisabeta Levcovici 313-993-0419 elevcovi@med.wayne.edu | |
| Contact: Hamza Aurakzai 313-745-7014 haurakza@dmc.org | |
| Principal Investigator: John Flack, MD | |
| Principal Investigator: Theodore Schreiber, MD | |
| St Joseph Mercy Oakland Hospital | Recruiting |
| Pontiac, Michigan, United States, 48341 | |
| Contact: Susan Oblak 248-858-6962 oblaks@trinity-health.org | |
| Principal Investigator: Kirit Patel, MD | |
| Providence Hospital | Recruiting |
| Southfield, Michigan, United States, 48075 | |
| Contact: Jean Kelly, RN 248-849-3369 jeankelly@stjohn.org | |
| Principal Investigator: Susan Steigerwalt, MD | |
| Principal Investigator: Shukri David, MD | |
| Michigan Heart, St. Joseph Mercy Health System | Recruiting |
| Ypsilanti, Michigan, United States, 48197 | |
| Contact: Kristy Wippler, RN 734-712-7602 kwippler@michiganheart.com | |
| Principal Investigator: Herbert Aronow, MD | |
| United States, Minnesota | |
| Abbott Northwestern/Minneapolis Heart Institute Foundation | Recruiting |
| Minneapolis, Minnesota, United States, 55407 | |
| Contact: Holly MacDonald, RN 612-863-6051 Holly.macdonald@allina.com | |
| Principal Investigator: Yale Wang, MD | |
| Saint Mary's Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Karen Miller 507-266-5359 miller.karen1@mayo.edu | |
| Principal Investigator: Rajiv Gulati, MD, PhD | |
| United States, Mississippi | |
| Hattiesburg Clinic, P.A | Recruiting |
| Hattiesburg, Mississippi, United States, 39401 | |
| Contact: Frances Findley 601-268-5794 frances.findley@hattiesburgclinic.com | |
| Principal Investigator: Bryan Batson, MD | |
| Principal Investigator: Robert Wilkins, MD | |
| United States, Missouri | |
| Saint Luke's Hospital of Kansas City/Mid America Heart Institute | Recruiting |
| Kansas City, Missouri, United States, 64111 | |
| Contact: Steven Marso, MD 816-932-5773 smarso@cc-pc.com | |
| Contact: Cheryl Rutherford, RN 816-932-5773 cjrutherford@saint-lukes.org | |
| Principal Investigator: Steven Marso, MD | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Margie Palazzolo, RN, BSN 314-362-1962 mpalazzo@dom.wustl.edu | |
| Principal Investigator: Jasvindar Singh, MD | |
| Principal Investigator: Angela Brown, MD | |
| United States, New Jersey | |
| Deborah Heart & Lung Center | Recruiting |
| Browns Mills, New Jersey, United States, 08015 | |
| Contact: Linda Dewey, RN,MSN,CCRC 609-893-6611 ext 5023 deweyl@deborah.org | |
| Principal Investigator: Richard Kovach, MD | |
| Morristown Medical Center | Recruiting |
| Morristown, New Jersey, United States, 07962 | |
| Contact: Janet Scherer 973-971-8596 Janet.Scherer@atlantichealth.org | |
| Principal Investigator: Maurice Buchbinder, MD | |
| Jersey Shore University Medical Center | Recruiting |
| Neptune, New Jersey, United States, 07753 | |
| Contact: Linda Murphy 732-776-4796 Lmurphy@Meridianhealth.com | |
| Principal Investigator: Ziad Abbud, MD | |
| United States, New York | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Faraj Alguaraghui, RN 718-920-7376 Falgra@montefiore.org | |
| Principal Investigator: David Slovut, MD, PhD | |
| SUNY Downstate Medical Center | Recruiting |
| Brooklyn, New York, United States, 11203 | |
| Contact: Ilona Raskina, NP 718-270-2107 Ilona.raskina@downstate.edu | |
| Principal Investigator: Jacek Preibisz, MD | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Kate Dalton, MS,RD 212-342-1820 keb2114@columbia.edu | |
| Principal Investigator: Ajay Kirtane, MD | |
| Weill Cornell Medical College | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Tessa Scott 212-746-6914 tes2009@med.cornell.edu | |
| Contact: Samuel Mann, MD 212.746.2200 sjmann@med.cornell.edu | |
| Principal Investigator: Samuel Mann, MD | |
| Mount Sinai Medical Center-Manhattan | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Theresa Franklin-Bond 212-659-9647 theresa.franklin-bond@mssm.edu | |
| Contact: Laura Ramirez lalura.ramirez@mountsinai.org | |
| Principal Investigator: George Dangas, MD | |
| New York University Medical Center | Recruiting |
| New York, New York, United States, 10015 | |
| Contact: Patrick Sturges 212-263-4217 Patrick.sturges@nyumc.org | |
| Principal Investigator: Anvar Babaev, MD,PhD | |
| St. Francis Hospital | Recruiting |
| Roslyn, New York, United States, 11576 | |
| Contact: Elizabeth Haag, RN, MPA, CCRP 828-365-1084 Elizabeth.Haag@chsli.org | |
| Principal Investigator: George Petrossian, MD | |
| Principal Investigator: Richard Shlofmitz, MD | |
| Stony Brook University Hospital and Medical Center | Recruiting |
| Stony Brook, New York, United States, 11794 | |
| Contact: Jacqueline Skarre, RN 631-444-9033 Jacqueline.skarre@sbumed.org | |
| Principal Investigator: Luis Gruberg, MD | |
| United States, North Carolina | |
| University of North Carolina Heart and Vascular | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Cassie Ramm, RN,BSN 919-843-1610 Cassandra_ramm@med.unc.edu | |
| Principal Investigator: George (Rick) Stouffer, MD | |
| Carolinas Healthcare (SHVI)-Clinical Research | Recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| Contact: William Downey, MD 704-373-0212 William.Downey@carolinashealthcare.org | |
| Principal Investigator: William Downey, MD | |
| Duke University Health System | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Debra Schumm 919-660-6882 debra.schumm@dm.duke.edu | |
| Principal Investigator: Laura Svetkey, MD | |
| Principal Investigator: Manesh Patel, MD | |
| Wake Forest Baptist Health | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Deborah Wesley, RN,BSn,CCRC,CCA 336-716-2924 dwesley@wakehealth.edu | |
| Principal Investigator: Dr. William Little | |
| United States, Ohio | |
| The Lindner Center for Research & Education at The Christ Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45219 | |
| Contact: David M White, RN 513-585-2198 David.White@thechristhospital.com | |
| Principal Investigator: Eugene Chung, MD | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Mehdi Shishehbor, DO 216-445-6397 | |
| Contact: George Thomas, MD 216-445-6397 | |
| Principal Investigator: Mehdi Shishehbor, DO | |
| Principal Investigator: George Thomas, MD | |
| University Hospitals Case Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Terence Semenec, RN 216-983-4724 Terence.Semenec@uhhospitals.org | |
| Principal Investigator: Sahil A Parikh, MD | |
| Principal Investigator: Jackson Wright Jr, MD,PHD | |
| The MetroHealth System | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Mary Dettmer, RN, BSN, CCRC (216)778-2223 mdettmer@metrohealth.org | |
| Principal Investigator: Mark Dunlap, MD | |
| OhioHealth Research Institute | Recruiting |
| Columbus, Ohio, United States, 43214-3907 | |
| Contact: Metz William 614-566-1258 wmetz@ohiohealth.com | |
| Principal Investigator: Mitchell Silver, DO | |
| The Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Denise Fadorsen, RN 614-292-5315 denise.fadorsen@osumc.edu | |
| Principal Investigator: Ernest Mazzaferri Jr., MD | |
| United States, Pennsylvania | |
| Geisinger Medical Center | Recruiting |
| Danville, Pennsylvania, United States, 17822 | |
| Contact: Susan Kilbride, MS, CCRC 570-271-8492 | |
| Principal Investigator: Thomas Scott, DO | |
| Lancaster General Hospital | Recruiting |
| Lancaster, Pennsylvania, United States, 17604 | |
| Contact: Kay Knepper, RN 717-544-5951 KMKneppe@lghealth.org | |
| Principal Investigator: Paul Casale, MD | |
| University of Pennsylvania Health System | Recruiting |
| Philadelphia, Pennsylvania, United States, 19130 | |
| Contact: Robin Neubauer, RN 215-615-0773 robin.neubauer@uphs.upenn.edu | |
| Principal Investigator: Debbie Cohen-Stein, MD | |
| Thomas Jefferson University Hospitals, Inc | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Lisha Anthony 215-503-5521 lisha.anthony@jefferson.edu | |
| Principal Investigator: Nicholas Ruggiero II, MD | |
| UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Lisa Baxendell, RN,CCRC 412-802-8672 baxelx@upmc.edu | |
| Principal Investigator: John Schindler, MD | |
| Lankenau Medical Center | Recruiting |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Contact: Eric Gnall 484-476-3030 gnalle@mlhs.org | |
| Principal Investigator: Dr. Eric Gnall | |
| Principal Investigator: Dr. Geoffrey Teehan | |
| United States, Rhode Island | |
| Vascular Disease Research Center at Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Gait Jordan 401-444-6208 pjordan@lifespan.org | |
| Principal Investigator: Timothy P Murphy, MD | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Mariann Schultz 843-876-5383 schulzmt@musc.edu | |
| Principal Investigator: Thomas Todoran, MD | |
| United States, Tennessee | |
| Memorial Research Center/ Chattanooga Heart Institute | Recruiting |
| Chattanooga, Tennessee, United States, 37404 | |
| Contact: Debbie Dyer 423-495-4775 deborah_dyer@memorial.org | |
| Principal Investigator: Brian H Negus, MD | |
| Stern Cardiovascular Foundation, Inc. | Recruiting |
| Memphis, Tennessee, United States, 38138 | |
| Contact: Jessica Foon, RC 901-271-1000 jessica.foon@sterncardio.com | |
| Principal Investigator: Basil Paulus, MD | |
| Vanderbilt Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232-7235 | |
| Contact: Sean Johnson, RN 615-322-9349 sean.a.johnson@vanderbilt.edu | |
| Principal Investigator: Mark Robbins, MD | |
| United States, Texas | |
| Austin Heart PLLC / Heart Hospital of Austin | Recruiting |
| Austin, Texas, United States, 78756 | |
| Contact: Paige Musick, RN,BSN,CCRC 512-421-3896 Paige.Musick@HCAHealthcare.com | |
| Principal Investigator: Frank Zidar, MD, FACC, FSCAI | |
| University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Dana Red 214-590-5015 Dana.Red@UTSouthwestern.edu | |
| Principal Investigator: Tayo Addo, MD | |
| Soltero Cardiovascular Research Center - Baylor Jack and Jane Hamilton Heart & Vascular Hospital | Recruiting |
| Dallas, Texas, United States, 75226 | |
| Contact: Merielle Boatman 214-820-2273 merielle.boatman@baylorhealth.edu | |
| Principal Investigator: James Choi, MD | |
| VA North Texas Health Care System | Recruiting |
| Dallas, Texas, United States, 75216 | |
| Contact: Preeti Kamath 214-857-0305 Preeti.Kamath@va.gov | |
| Principal Investigator: Ahmad Zankar, MD | |
| University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Truc Baccam 713-500-5214 ms.hypertension@uth.tmc.edu | |
| Principal Investigator: Ali Denktas, MD | |
| The Methodist Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Paula Juarez, RN 713-441-3672 pvjuarez@tmhs.org | |
| Principal Investigator: Mark Davies, MD | |
| The Heart Hospital Baylor Plano | Recruiting |
| Plano, Texas, United States, 75093 | |
| Contact: Amy Barnette, B.S., CCRC 469-814-4737 amy.barnette@baylorhealth.edu | |
| Principal Investigator: David Brown, MD | |
| Scott & White Healthcare | Recruiting |
| Temple, Texas, United States, 76508 | |
| Contact: Andrea Missy Jackson 254-724-6741 ajackson@sw.org | |
| Principal Investigator: Sheldon Chaffer, MD | |
| United States, Vermont | |
| Fletcher Allen Health Care | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Amy Henderson 802-847-4746 Harold.dauerman@vtmednet.org | |
| Contact: Faye Straight (802) 847-4746 Richard.solomon@vtmednet.org | |
| Principal Investigator: Harold Dauerman, MD | |
| Principal Investigator: Richard Solomon, MD | |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Doug Spaulding, RN 434-243-0315 uvastac@virginia.edu | |
| Principal Investigator: John Fritz Angle, MD | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Melissa Sears, RN,BSN 804-828-1601 mlsears@vcu.edu | |
| Principal Investigator: George Vetrovec | |
| Principal Investigator: Domenic Sica | |
| United States, Washington | |
| Providence Medical Research Center | Recruiting |
| Spokane, Washington, United States, 99204 | |
| Contact: Ruthie Franks, RN, CCRC 509-474-4345 ruth.franks@providence.org | |
| Principal Investigator: Michael E Ring, MD | |
| Principal Investigator: Katherine R Tuttle, MD | |
| United States, Wisconsin | |
| Aurora St. Luke's Medical Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53215 | |
| Contact: Dena Gustafson, RN,BSN 414-649-3490 dena.gustafson@aurora.org | |
| Principal Investigator: Anjan Gupta | |
| Wheaton Franciscan Healthcare-All Saints | Recruiting |
| Racine, Wisconsin, United States, 53405 | |
| Contact: Timothy J Babin 262.687.8138 timothy.babin@wfhc.org | |
| Principal Investigator: Thomas Shimshak, MD,FACC,FSCAI | |
Sponsors and Collaborators
Medtronic Vascular
Investigators
| Principal Investigator: | George Bakris, MD | Professor of Medicine, Hypertension Center Director University of Chicago Medical Center |
| Principal Investigator: | Deepak L Bhatt, MD, MPH | VA Boston Healthcare System Department of Cardiology |
More Information
No publications provided
| Responsible Party: | Medtronic Vascular |
| ClinicalTrials.gov Identifier: | NCT01418261 History of Changes |
| Other Study ID Numbers: | IP125 |
| Study First Received: | August 15, 2011 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Medtronic Vascular:
|
uncontrolled hypertension renal denervation |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013