N/A
N=68
Observational Study of the EnligHTN Renal Denervation System in Europe
Uncontrolled Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02006758 ↗Enrolled (actual)
68
Serious AEs
11.8%
Results posted
Oct 2019
Primary outcome: Primary: Mean Change in Office Systolic Blood Pressure at 6 Months — -13.6 mmHg
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- EnligHTN™ Renal Denervation System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Office Systolic Blood Pressure at 6 Months |
-13.6 | — |
| SECONDARY Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure |
1; 1; 1; 1 | — |
| SECONDARY Mean Change in Office Systolic Blood Pressure at 1 Month |
-13.0 | — |
| SECONDARY Mean Change in Office Diastolic Blood Pressure at 1 Month |
-4.6 | — |
| SECONDARY Mean Change in Ambulatory Systolic Blood Pressure at 1 Month |
-6.8 | — |
| SECONDARY Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month |
-3.6 | — |
| SECONDARY Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month |
24 | — |
| SECONDARY Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months |
-1.0 | — |
| SECONDARY Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months |
-2.2 | — |
| SECONDARY Renovascular Safety at 6 Months (Renal Artery Stenosis) |
1 | — |
| SECONDARY Mean Change in Office Systolic Blood Pressure at 12 Months |
-13.8 | — |
| SECONDARY Mean Change in Office Diastolic Blood Pressure at 6 Months |
-6.7 | — |
| SECONDARY Mean Change in Office Diastolic Blood Pressure at 12 Months |
-7.1 | — |
| SECONDARY Mean Change in Ambulatory Systolic Blood Pressure at 6 Months |
-10.8 | — |
| SECONDARY Mean Change in Ambulatory Systolic Blood Pressure at 12 Months |
-6.4 | — |
| SECONDARY Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months |
-5.6 | — |
| SECONDARY Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months |
-4.2 | — |
| SECONDARY Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months |
21 | — |
| SECONDARY Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months |
19 | — |
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 participants with uncontrolled hypertension in clinical routine practice.
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 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)
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 to impact his/her hypertension management (pharmaceutical/ device/ homeopathic)
- Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
- Subject has active systemic infection
- Subject has known renal arteries with diameter(s) < 4 mm
- Subject has an estimated GFR <45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
- Subject had a renal transplant or is awaiting a renal transplant
Data sourced from ClinicalTrials.gov (NCT02006758). 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.