NCT01903187

EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for Hypertension

Multi-center, Randomized, Single-blind, Sham Controlled Clinical Investigation of Renal Denervation for Uncontrolled Hypertension

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the EnligHTN IV clinical investigation is to demonstrate the safety and effectiveness of the EnligHTN™ Renal Denervation System in the treatment of subjects with drug-resistant uncontrolled hypertension.

Detailed description

The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. Subject randomized to the treatment group will be followed up for three years post procedure.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	EnligHTN Renal Denervation	Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
PROCEDURE	Sham	Renal artery angiogram

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-06-01
• Completion: 2016-11-01
• First posted: 2013-07-19
• Last updated: 2019-02-15
• Results posted: 2016-03-17

Locations

3 sites across 1 country: United States