NCT02690909

A Study to Evaluate Safety and Efficacy of the Redy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension

A Prospective, Post-marketing, Single-arm, Open Label, Multi-center Clinical Study to Evaluate the Safety and Efficacy of the ReDy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Renal Dynamics GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The ReDy™ System (Renal Dynamics) is a renal denervation device incorporating a variety of ablation features and technical improvements over previously designed systems into a single product. It is intended to treat uncontrolled (drug-resistant) hypertension by RF ablation of the sympathetic nerve network surrounding the renal arteries. This study will be carried out to validate the safety and the efficacy of the ReDy™ Renal Denervation device and to demonstrate that it performs according to its intended use, i.e. the treatment of patients with uncontrolled hypertension.

Conditions

• Hypertension Resistant to Conventional Therapy

Interventions

Type	Name	Description
DEVICE	Redy™ Renal Denervation System	Renal Denervation System

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-04-01
• Completion: 2017-08-01
• First posted: 2016-02-24
• Last updated: 2016-05-11

Locations

10 sites across 8 countries: Belgium, Germany, Hungary, Ireland, Israel, Poland, Russia, Serbia