NCT02295683

Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - Iberis-HTN Registry

Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - IBERIS - HTN Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Terumo Europe N.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to document safety and efficacy of renal sympathetic denervation treatment in subjects with uncontrolled hypertension by using Iberis renal denervation system.

Detailed description

This study is a prospective, multi-center, single-arm, non-interventional and open-label registry to collect descriptive data from patients who receive renal sympathetic denervation treatment in accordance with routine hospital practice using Iberis system. This registry will collect data prospectively from patients that receive renal sympathetic denervation treatment with use of Iberis renal denervation system and treatment will be applied according to the routine hospital practice. No additional tests are required specific to this registry. The registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, efficacy and functionality of the Iberis system in patients with resistant hypertension. A minimum of 30 patients will be enrolled in Europe

Conditions

• Resistant Hypertension

Interventions

Type	Name	Description
DEVICE	Renal Denervation

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-11-30
• Completion: 2017-09-04
• First posted: 2014-11-20
• Last updated: 2019-10-08

Locations

2 sites across 2 countries: Serbia, Spain