EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension

Completed

• Conditions: Uncontrolled Hypertension

• Registration Number: NCT01996033
• 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 patients with uncontrolled hypertension in clinical routine practice.

Detailed 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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-27
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Results First Submitted: 2018-02-05
• Results First Submitted QC: 2018-02-05
• Results First Posted: 2018-09-28
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Reduction in Office Systolic Blood Pressure at 6 Months	6 months	Positive number indicates a reduction (improvement) in blood pressure

Trial Locations

Locations (12)

Klinikum Ernst von Bergmann; 🇩🇪 Potsdam, Brandenburg, Germany

Immanuelklinikum Bernau und Herzzentrum Brandenburg; 🇩🇪 Bernau, Brandenburg, Germany

Asklepios Schwalm-Eder-Kliniken GmbH; 🇩🇪 Schwalmstadt, Hesse, Germany

Kliniken Villingen-Schwenningen; 🇩🇪 Villingen-Schwenningen, Baden-Wurttemberg, Germany

Klinikum Oldenburg gGmbH; 🇩🇪 Oldenburg, Niedersachsen, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Saxony, Germany

Kliniken Oberallgäu gGmbH Klinik Immenstadt; 🇩🇪 Immenstadt, Bayern, Germany

Medizinische Einrichtungen der Universität Düsseldorf; 🇩🇪 Düsseldorf, Northrhine-Westphalia, Germany

Elisabeth-Krankenhaus Essen; 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Kardiologische Praxis Wuppertal; 🇩🇪 Wuppertal, Northrhine-Westphalia, Germany

Diakonie-Klinikum Schwäbisch Hall gGmbH; 🇩🇪 Schwäbisch Hall, Germany

Augusta-Krankenhaus Düsseldorf; 🇩🇪 Düsseldorf, Germany