Overview

This trial is active, not recruiting.

Condition uncontrolled hypertension
Treatment enlightn™ renal denervation system
Sponsor St. Jude Medical
Start date November 2013
End date August 2017
Trial size 68 participants
Trial identifier NCT02006758, CV-12-064-EU-HT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
The study will enroll 500 patients planned to undergo a renal denervation procedure (with the 'EnligHTN™ Renal Denervation System') for the treatment of their uncontrolled hypertension.
enlightn™ renal denervation system
The EnligHTN™ Renal Denervation System is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The system consists of the EnligHTN™ RF Ablation Generator (generator), the EnligHTN™ Renal Artery Ablation Catheter (ablation catheter), and the EnligHTN™ Guiding Catheter (optional).

Primary Outcomes

Measure
Mean reduction in office Systolic BP
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 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

Additional Information

Official title EnligHTN European Observational Study
Principal investigator José Diaz, MD
Description The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.