Trials / Completed
CompletedNCT01996033
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2017-01-01
- Completion
- 2017-01-01
- First posted
- 2013-11-27
- Last updated
- 2019-02-04
- Results posted
- 2018-09-28
Locations
12 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01996033. Inclusion in this directory is not an endorsement.