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

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.

Study Overview

• Status: Completed
• Conditions: Uncontrolled Hypertension

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Germany
  • Düsseldorf, Germany, 40472
    • Augusta-Krankenhaus Düsseldorf
  • Schwäbisch Hall, Germany, 74523
    • Diakonie-Klinikum Schwäbisch Hall gGmbH
  • Baden-Wurttemberg
    • Villingen-Schwenningen, Baden-Wurttemberg, Germany, 78052
      • Kliniken Villingen-Schwenningen
  • Bayern
    • Immenstadt, Bayern, Germany, 87509
      • Kliniken Oberallgäu gGmbH Klinik Immenstadt
  • Brandenburg
    • Bernau, Brandenburg, Germany, 16321
      • Immanuelklinikum Bernau und Herzzentrum Brandenburg
    • Potsdam, Brandenburg, Germany, 14467
      • Klinikum Ernst von Bergmann
  • Hesse
    • Schwalmstadt, Hesse, Germany, 34613
      • Asklepios Schwalm-Eder-Kliniken GmbH
  • Niedersachsen
    • Oldenburg, Niedersachsen, Germany, 26133
      • Klinikum Oldenburg gGmbH
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45138
      • Elisabeth-Krankenhaus Essen
  • Northrhine-Westphalia
    • Düsseldorf, Northrhine-Westphalia, Germany, 40225
      • Medizinische Einrichtungen der Universität Düsseldorf
    • Wuppertal, Northrhine-Westphalia, Germany, 42103
      • Kardiologische Praxis Wuppertal
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Universitatsklinikum Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patient population enrolled in this investigation will consist of males and females with uncontrolled hypertension who meet all inclusion criteria, and none of the exclusion criteria.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Reduction in Office Systolic Blood Pressure at 6 Months	Positive number indicates a reduction (improvement) in blood pressure	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Office Diastolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	6 Months
Reduction in Office Diastolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	12 Months
Reduction in Office Systolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	12 Months
Reduction in 24 Hour Ambulatory Systolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	12 Months
Reduction in 24 Hour Ambulatory Diastolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	12 Months
Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	1 Month
Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	6 Months
Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	12 Months
Change in Estimated Glomerular Filtration Rate (eGFR)	Change from baseline in eGFR	12 Months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Christoph K Naber, MD, Elisabeth-Krankenhaus Essen, Germany

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: uncontrolled hypertension; Renal Denervation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CV-12-064-GE-HT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO