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EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01996033
First Posted: November 27, 2013
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  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: This is a Post Market, Multi-center, Open Label, Observational Study. Approximately 500 Subjects With Uncontrolled Hypertension Will Undergo Renal Artery Ablation

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 ]

Enrollment: 25
Study Start Date: October 2013
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Detailed Description:
This is a post market, multi-center, open label, observational study. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located in Germany and will be followed for 1 year post procedure.The expected duration of the investigation will be approximately 4 years.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01996033


Locations
Germany
Kliniken Villingen-Schwenningen
Villingen-Schwenningen, Baden-Wurttemberg, Germany, 78052
Kliniken Oberallgäu gGmbH Klinik Immenstadt
Immenstadt, Bayern, Germany, 87509
Immanuelklinikum Bernau und Herzzentrum Brandenburg
Bernau, Brandenburg, Germany, 16321
Klinikum Ernst von Bergmann
Potsdam, Brandenburg, Germany, 14467
Asklepios Schwalm-Eder-Kliniken GmbH
Schwalmstadt, Hesse, Germany, 34613
Klinikum Oldenburg gGmbH
Oldenburg, Niedersachsen, Germany, 26133
Elisabeth-Krankenhaus Essen
Essen, Nordrhein-Westfalen, Germany, 45138
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf, Northrhine-Westphalia, Germany, 40225
Kardiologische Praxis Wuppertal
Wuppertal, Northrhine-Westphalia, Germany, 42103
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany, 04103
Augusta-Krankenhaus Düsseldorf
Düsseldorf, Germany, 40472
Diakonie-Klinikum Schwäbisch Hall gGmbH
Schwäbisch Hall, Germany, 74523
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Christoph K Naber, MD Elisabeth-Krankenhaus Essen, Germany
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01996033     History of Changes
Other Study ID Numbers: CV-12-064-GE-HT
First Submitted: November 21, 2013
First Posted: November 27, 2013
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases