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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

November 21, 2013
July 31, 2014
October 2013
January 2016   (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
Not Provided
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EnligHTN German Observational Study
EnligHTN German Observational Study

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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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
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
January 2016
January 2016   (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
No
Contact: Anne Siemerkus asiemerkus@sjm.com
Germany
 
NCT01996033
CV-12-064-GE-HT
No
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Christoph K Naber, MD Elisabeth-Krankenhaus Essen, Germany
St. Jude Medical
July 2014

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