NCT01996033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

September 28, 2018

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

3.3 years

First QC Date

November 21, 2013

Results QC Date

February 5, 2018

Last Update Submit

January 31, 2019

Conditions

Uncontrolled Hypertension

Keywords

uncontrolled hypertensionRenal Denervation

Outcome Measures

Primary Outcomes (1)

  • Mean Reduction in Office Systolic Blood Pressure at 6 Months

    Positive number indicates a reduction (improvement) in blood pressure

    6 months

Other Outcomes (9)

  • Reduction in Office Diastolic Blood Pressure

    6 Months

  • Reduction in Office Diastolic Blood Pressure

    12 Months

  • Reduction in Office Systolic Blood Pressure

    12 Months

  • +6 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Kliniken Villingen-Schwenningen

Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany

Location

Kliniken Oberallgäu gGmbH Klinik Immenstadt

Immenstadt im Allgäu, Bavaria, 87509, Germany

Location

Immanuelklinikum Bernau und Herzzentrum Brandenburg

Bernau bei Berlin, Brandenburg, 16321, Germany

Location

Klinikum Ernst von Bergmann

Potsdam, Brandenburg, 14467, Germany

Location

Asklepios Schwalm-Eder-Kliniken GmbH

Schwalmstadt, Hesse, 34613, Germany

Location

Klinikum Oldenburg gGmbH

Oldenburg, Lower Saxony, 26133, Germany

Location

Medizinische Einrichtungen der Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Elisabeth-Krankenhaus Essen

Essen, North Rhine-Westphalia, 45138, Germany

Location

Kardiologische Praxis Wuppertal

Wuppertal, North Rhine-Westphalia, 42103, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Augusta-Krankenhaus Düsseldorf

Düsseldorf, 40472, Germany

Location

Diakonie-Klinikum Schwäbisch Hall gGmbH

Schwäbisch Hall, 74523, Germany

Location

Results Point of Contact

Title
Steven Madej
Organization
Abbott
steven.madej@abbott.com
651-756-2230

Study Officials

  • Christoph K Naber, MD

    Elisabeth-Krankenhaus Essen, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2013

First Posted

November 27, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 4, 2019

Results First Posted

September 28, 2018

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(12)