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EnligHTN German Observational Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: November 21, 2013
Last updated: July 19, 2016
Last verified: July 2016
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.

Uncontrolled Hypertension

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

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: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

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 identifier: NCT01996033

Contact: Anne Siemerkus

Städtisches Klinikum Karlsruhe Recruiting
Karlsruhe, Baden-Württemberg, Germany, 76133
Contact: Claus Schmitt, Prof. Dr. med.    0721-974-2901   
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   
Principal Investigator: Werner Jung, Prof. Dr. med.         
Kliniken Oberallgäu gGmbH Klinik Immenstadt Recruiting
Immenstadt, Bayern, Germany, 87509
Contact: wulf Ito   
Helios Klinikum Bad Saarow Recruiting
Bad Saarow, Brandenburg, Germany, 15526
Contact: Jan Monti, PD Dr. med.   
Principal Investigator: Jan Monti, PD Dr. med.         
Immanuelklinikum Bernau und Herzzentrum Brandenburg Recruiting
Bernau, Brandenburg, Germany, 16321
Contact: Christian Butter, PD Dr. med.   
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.   
Principal Investigator: Annette D Fengler, Dr.         
Asklepios Schwalm-Eder-Kliniken GmbH Recruiting
Schwalmstadt, Hesse, Germany, 34613
Contact: Matthias Schulze, Dr.   
Principal Investigator: Matthias Schulze, Dr.         
Klinikum Oldenburg gGmbH Recruiting
Oldenburg, Niedersachsen, Germany, 26133
Contact: Claus Lüers, Dr. med.   
Contact: Albrecht Elsässer, Prof. Dr. med.   
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   
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   
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   
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   
Principal Investigator: Roger Gerke, Dr. med.         
Sub-Investigator: Ulrich Fahrenkrog, Dr. med.         
Universitätsklinikum Leipzig Active, not recruiting
Leipzig, Saxony, Germany, 04103
Vivantes Klinikum im Friedrichshain Recruiting
Berlin, Germany, 10249
Contact: Stephan Kische, PD Dr. med.   
Principal Investigator: Stephan Kische, PD Dr. med.         
Augusta-Krankenhaus Düsseldorf Recruiting
Düsseldorf, Germany, 40472
Contact: Rolf M Klein, Prof. Dr. med.         
Principal Investigator: Rolf M Klein, Prof. Dr. med.         
Evangelisches Krankenhaus Oberhausen Withdrawn
Oberhausen, Germany, 46047
Diakonie-Klinikum Schwäbisch Hall gGmbH Recruiting
Schäbisch Hall, Germany, 74523
Contact: Alexander Bauer, Prof. Dr. med.   
Principal Investigator: Alexander Bauer, Prof. Dr. med.         
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Christoph K Naber, MD Elisabeth-Krankenhaus Essen, Germany
  More Information

Responsible Party: St. Jude Medical Identifier: NCT01996033     History of Changes
Other Study ID Numbers: CV-12-064-GE-HT 
Study First Received: November 21, 2013
Last Updated: July 19, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on September 28, 2016