Trials / Terminated
TerminatedNCT01705080
IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN
IntErnational Non-randomized, Single-arm, Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 276 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this post market clinical investigation is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension.
Detailed description
This is a post market, prospective, multicenter, non-randomized, single arm study of the EnligHTN™ Renal Denervation System. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located internationally and will be followed up to five years post procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EnligHTN | Renal artery ablation with EnligHTN system used for all groups |
Timeline
- Start date
- 2013-01-17
- Primary completion
- 2017-04-01
- Completion
- 2019-11-27
- First posted
- 2012-10-12
- Last updated
- 2021-05-27
- Results posted
- 2018-09-14
Locations
33 sites across 11 countries: Australia, France, Germany, Greece, Italy, Netherlands, New Zealand, Norway, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01705080. Inclusion in this directory is not an endorsement.