Observational Study of the EnligHTN Renal Denervation System in Europe

Completed

• Conditions: Uncontrolled Hypertension
• Interventions: Device: EnligHTN™ Renal Denervation System

• Registration Number: NCT02006758
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description

The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2019-08
• Results First Submitted: 2019-08-02
• Results First Submitted QC: 2019-10-14
• Last Update Submitted: 2019-10-14
• Results First Posted: 2019-10-16
• Last Update Posted: 2019-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Uncontrolled hypertension patients	EnligHTN™ Renal Denervation System	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.

Primary Outcome Measures

Name	Time	Method
Mean Change in Office Systolic Blood Pressure at 6 Months	Baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months	12 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months	6 months
Mean Change in Ambulatory Systolic Blood Pressure at 6 Months	Baseline and 6 months
Mean Change in Ambulatory Systolic Blood Pressure at 12 Months	Baseline and 12 months
Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month	Baseline and 1 month
Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month	1 month
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months	Baseline and 6 months
Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure	30 days
Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months	Baseline and 12 months
Mean Change in Office Systolic Blood Pressure at 1 Month	Baseline and 1 month
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months	Baseline and 12 months
Mean Change in Office Diastolic Blood Pressure at 1 Month	Baseline and 1 month
Mean Change in Ambulatory Systolic Blood Pressure at 1 Month	Baseline and 1 month
Renovascular Safety at 6 Months (Renal Artery Stenosis)	6 months	Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation.
Mean Change in Office Systolic Blood Pressure at 12 Months	Baseline and 12 months
Mean Change in Office Diastolic Blood Pressure at 6 Months	Baseline and 6 months
Mean Change in Office Diastolic Blood Pressure at 12 Months	Baseline and 12 months
Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months	Baseline and 6 months

Trial Locations

Locations (13)

Hospital de Santa Cruz; 🇵🇹 Carnaxide, Lisbon, Portugal

Hôpital Civil Marie Curie; 🇧🇪 Lodelinsart, Hainaut, Belgium

Policlinico San Marco; 🇮🇹 Osio Sotto, Lombardy, Italy

Clinica San Gaudenzio; 🇮🇹 Novara, Peimonte, Italy

North Estonia Medical Centre; 🇪🇪 Tallinn, Harjuma, Estonia

Instituto Clinico Citta Studi; 🇮🇹 Milano, Lombardy, Italy

Dr. Gianluigi Patelli; 🇮🇹 Alzano Lombardo, Lombardia, Italy

Hospital Xeral-Cies de Vigo; 🇪🇸 Vigo, Spain

Clinica Universitaria de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Juan Ramon Jimenez; 🇪🇸 Huelva, Andalucia, Spain

Hopspital Infanta Cristina; 🇪🇸 Badajoz, Spain

Hospital Universitari i Politecnic La Fe; 🇪🇸 Valencia, Spain

Craigavon Area Hospital; 🇬🇧 Portadown, Nirelnd, United Kingdom