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EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01996033
First received: November 21, 2013
Last updated: October 11, 2016
Last verified: October 2016

November 21, 2013
October 11, 2016
October 2013
July 2017   (final data collection date for primary outcome measure)
Mean reduction in office Systolic Blood Pressure at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01996033 on ClinicalTrials.gov Archive Site
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EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension
This is a Post Market, Multi-center, Open Label, Observational Study. Approximately 500 Subjects With Uncontrolled Hypertension Will Undergo Renal Artery Ablation
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
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.
Uncontrolled Hypertension
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
August 2017
July 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01996033
CV-12-064-GE-HT
No
No
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St. Jude Medical
St. Jude Medical
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Principal Investigator: Christoph K Naber, MD Elisabeth-Krankenhaus Essen, Germany
St. Jude Medical
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP