EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension

NCT ID: NCT01996033

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-01-31

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.

Conditions

Uncontrolled Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph K Naber, MD

Role: PRINCIPAL_INVESTIGATOR

Elisabeth-Krankenhaus Essen, Germany

Locations

Kliniken Villingen-Schwenningen

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Kliniken Oberallgäu gGmbH Klinik Immenstadt

Immenstadt im Allgäu, Bavaria, Germany

Immanuelklinikum Bernau und Herzzentrum Brandenburg

Bernau bei Berlin, Brandenburg, Germany

Klinikum Ernst von Bergmann

Potsdam, Brandenburg, Germany

Asklepios Schwalm-Eder-Kliniken GmbH

Schwalmstadt, Hesse, Germany

Klinikum Oldenburg gGmbH

Oldenburg, Lower Saxony, Germany

Medizinische Einrichtungen der Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Elisabeth-Krankenhaus Essen

Essen, North Rhine-Westphalia, Germany

Kardiologische Praxis Wuppertal

Wuppertal, North Rhine-Westphalia, Germany

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Augusta-Krankenhaus Düsseldorf

Düsseldorf, , Germany

Diakonie-Klinikum Schwäbisch Hall gGmbH

Schwäbisch Hall, , Germany

Countries

Germany

Other Identifiers

CV-12-064-GE-HT

Identifier Type: -

Identifier Source: org_study_id