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EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension | Clinical Trials | Clareo Health

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EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension

This is a Post Market, Multi-center, Open Label, Observational Study. Approximately 500 Subjects With Uncontrolled Hypertension Will Undergo Renal Artery Ablation

NCT01996033•Abbott Medical Devices

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (12)

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

Key Dates

Start Date

October 1, 2013

Primary Completion Date

January 1, 2017

Completion Date

January 1, 2017

Last Updated

February 4, 2019

Enrollment

ACTUAL participants

Conditions

Uncontrolled Hypertension

Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease

NCT05732727

Chronic Kidney Disease(CKD)Uncontrolled Hypertension

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RECRUITINGPHASE2

A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension

NCT07142356

Uncontrolled Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension

Inclusion Criteria

Exclusion Criteria

Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease

A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension

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A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension

A Phase I Trial of QLS1410 in Healthy Chinese Adults and Participants With Mild Essential Hypertension

Uncontrolled Hypertension Management (TEAM-HTN)