EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension

Uncontrolled Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01996033
• Other study ID #: CV-12-064-GE-HT
• Status: Completed
• Start date: October 2013
• Est. completion date: January 2017

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Locations

Country	Name	City	State
Germany	Immanuelklinikum Bernau und Herzzentrum Brandenburg	Bernau	Brandenburg
Germany	Augusta-Krankenhaus Düsseldorf	Düsseldorf
Germany	Medizinische Einrichtungen der Universität Düsseldorf	Düsseldorf	Northrhine-Westphalia
Germany	Elisabeth-Krankenhaus Essen	Essen	Nordrhein-Westfalen
Germany	Kliniken Oberallgäu gGmbH Klinik Immenstadt	Immenstadt	Bayern
Germany	Universitätsklinikum Leipzig	Leipzig	Saxony
Germany	Klinikum Oldenburg gGmbH	Oldenburg	Niedersachsen
Germany	Klinikum Ernst von Bergmann	Potsdam	Brandenburg
Germany	Diakonie-Klinikum Schwäbisch Hall gGmbH	Schwäbisch Hall
Germany	Asklepios Schwalm-Eder-Kliniken GmbH	Schwalmstadt	Hesse
Germany	Kliniken Villingen-Schwenningen	Villingen-Schwenningen	Baden-Wurttemberg
Germany	Kardiologische Praxis Wuppertal	Wuppertal	Northrhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduction in Office Diastolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	6 Months
Other	Reduction in Office Diastolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	12 Months
Other	Reduction in Office Systolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	12 Months
Other	Reduction in 24 Hour Ambulatory Systolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	12 Months
Other	Reduction in 24 Hour Ambulatory Diastolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	12 Months
Other	Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	1 Month
Other	Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	6 Months
Other	Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure	Positive number indicates a reduction (improvement) in blood pressure	12 Months
Other	Change in Estimated Glomerular Filtration Rate (eGFR)	Change from baseline in eGFR	12 Months
Primary	Mean Reduction in Office Systolic Blood Pressure at 6 Months	Positive number indicates a reduction (improvement) in blood pressure	6 months