This trial is active, not recruiting.

Condition uncontrolled hypertension
Sponsor St. Jude Medical
Start date October 2013
End date July 2017
Trial size 25 participants
Trial identifier NCT01996033, CV-12-064-GE-HT


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Mean reduction in office Systolic Blood Pressure at 6 months
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title This is a Post Market, Multi-center, Open Label, Observational Study. Approximately 500 Subjects With Uncontrolled Hypertension Will Undergo Renal Artery Ablation
Principal investigator Christoph K Naber, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.