EnligHTN German Observational Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01996033
First received: November 21, 2013
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension in clinical routine practice.


Condition
Uncontrolled Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: EnligHTN German Observational Study

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Mean reduction in office Systolic Blood Pressure at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: October 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The patient population enrolled in this investigation will consist of males and females with uncontrolled hypertension who meet all inclusion criteria, and none of the exclusion criteria.

Criteria

Inclusion Criteria:

  • Subject is planned to undergo a renal denervation procedure for the treatment of hypertension
  • Subject is ≥18 years of age at time of consent
  • Subject must be able and willing to provide written informed consent
  • Subject must be able and willing to comply with the required follow-up schedule
  • Subject has office Systolic Blood Pressure (SBP) ≥ 140 mmHg
  • Subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE-I/ Angiotensin Receptor Blocker (ARB), Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs

Exclusion Criteria:

  • Subject has known significant renovascular abnormalities such as renal artery stenosis > 30%
  • Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
  • Subject has a history of hemodynamically significant valvular heart disease
  • Subject has blood clotting abnormalities
  • Subject life expectancy is < 12 months, as determined by the Study Investigator
  • Subject is participating in another clinical study which has the potential
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996033

Contacts
Contact: Anne Siemerkus asiemerkus@sjm.com

Locations
Germany
Städtisches Klinikum Karlsruhe Recruiting
Karlsruhe, Baden-Württemberg, Germany, 76133
Contact: Claus Schmitt, Prof. Dr. med.    0721-974-2901    claus.schmitt@klinikum-karlsruhe.de   
Principal Investigator: Claus Schmitt, Prof. Dr. med.         
Sub-Investigator: Katharina Ruppender, Dr. med.         
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Recruiting
Villingen-Schwenningen, Baden-Württemberg, Germany, 78050
Contact: Werner Jung, Prof. Dr. med.    07721 / 93-3001    werner.jung@sbk-vs.de   
Principal Investigator: Werner Jung, Prof. Dr. med.         
Kliniken Oberallgäu gGmbH Klinik Immenstadt Recruiting
Immenstadt, Bayern, Germany, 87509
Contact: wulf Ito       wulf.ito@kliniken-oa.de   
Helios Klinikum Bad Saarow Recruiting
Bad Saarow, Brandenburg, Germany, 15526
Contact: Jan Monti, PD Dr. med.       jan.monti@helios-kliniken.de   
Principal Investigator: Jan Monti, PD Dr. med.         
Immanuelklinikum Bernau und Herzzentrum Brandenburg Recruiting
Bernau, Brandenburg, Germany, 16321
Contact: Christian Butter, PD Dr. med.       c.butter@immanuel.de   
Contact: Grit Tambor, Dr. med.         
Principal Investigator: Christian Butter, PD Dr. med.         
Sub-Investigator: Grit Tambor, Dr. med.         
Klinikum Ernst von Bergmann Recruiting
Potsdam, Brandenburg, Germany, 14467
Contact: Annette D Fengler, Dr.       stieger-fengler@web.de   
Principal Investigator: Annette D Fengler, Dr.         
Klinikum Oldenburg gGmbH Recruiting
Oldenburg, Niedersachsen, Germany, 26133
Contact: Claus Lüers, Dr. med.       luers.claus@klinikum-oldenburg.de   
Contact: Albrecht Elsässer, Prof. Dr. med.       kardiologie@klinikum-oldenburg.de   
Principal Investigator: Claus Lüers, Dr. med.         
Sub-Investigator: Albrecht Elsässer, Prof. Dr. med.         
Sub-Investigator: Torsten Schütz, Dr. med.         
Elisabeth-Krankenhaus Essen Recruiting
Essen, Nordrhein-Westfalen, Germany, 45138
Contact: Christoph K Naber, MD       c.k.naber@contilia.de   
Principal Investigator: Christoph K Naber, PD Dr. med.         
Sub-Investigator: Lioba Waidelich, Dr. med.         
Sub-Investigator: Thomas Schmitz, Dr. med.         
Städtische Kliniken Mönchengladbach GmbH Elisabeth-Krankenhaus Rheydt Withdrawn
Mönchengladbach, Nordrhein-Westfalen, Germany, 41239
St. Josef-Hospital Bochum Recruiting
Bochum, Northrhine-Westphalia, Germany, 44791
Contact: Kaffer Kara, Dr. med.    0234-5096303    k.kara@klinikum-bochum.de   
Principal Investigator: Kaffer Kara, Dr. med.         
Medizinische Einrichtungen der Universität Düsseldorf Recruiting
Düsseldorf, Northrhine-Westphalia, Germany, 40225
Contact: Johannes Stegbauer, Dr. med.    0 211- 8 11 75 02    johannes.stegbauer@med.uni-duesseldorf.de   
Principal Investigator: Johannes Stegbauer, Dr. med.         
Sub-Investigator: Sebastian Potthoff, Dr. med.         
Sub-Investigator: Patric Kröpil, PD Dr. med.         
Kardiologische Praxis Wuppertal Recruiting
Wuppertal, Northrhine-Westphalia, Germany, 42103
Contact: Roger Gerke, Dr. med.    0202 302050    rogerke@t-online.de   
Principal Investigator: Roger Gerke, Dr. med.         
Sub-Investigator: Ulrich Fahrenkrog, Dr. med.         
Universitätsklinikum Leipzig Recruiting
Leipzig, Saxony, Germany, 04103
Contact: Sebastian Reinhardt, Dr. med.       Sebastian.Reinhardt@medizin.uni-leipzig.de   
Principal Investigator: Sebastian Reinhardt, Dr. med.         
Sub-Investigator: Norbert Klein, Dr. med.         
Sub-Investigator: Christian Kühne, Dr. med.         
Evangelisches Krankenhaus Oberhausen Not yet recruiting
Oberhausen, Germany, 46047
Contact: Georg Horstick, Prof. Dr. med.         
Principal Investigator: Georg Horstick, Prof. Dr. med.         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Christoph K Naber, MD Elisabeth-Krankenhaus Essen, Germany
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01996033     History of Changes
Other Study ID Numbers: CV-12-064-GE-HT
Study First Received: November 21, 2013
Last Updated: July 31, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by St. Jude Medical:
uncontrolled hypertension
Renal Denervation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014