N/A
Completed N=25
EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension
Uncontrolled Hypertension
Source: ClinicalTrials.gov NCT01996033 ↗
Enrolled (actual)
25
Serious AEs
20.0%
Results posted
Sep 2018
Primary outcomePrimary: Mean Reduction in Office Systolic Blood Pressure at 6 Months — 17.6 mmHg
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Reduction in Office Systolic Blood Pressure at 6 Months |
17.6 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01996033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.