Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02006758
Status:
COMPLETED
Last Update Posted:
2019-10-16
First Post:
2013-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observational Study of the EnligHTN Renal Denervation System in Europe
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
EnligHTN European Observational Study
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 participants with uncontrolled hypertension in clinical routine practice.
Detailed Description:
The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: