Clinical Trial: A Study to Evaluate Safety and Efficacy of the Redy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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 Unc
Brief 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.
Detailed Summary:
Sponsor: Renal Dynamics GmbH
Current Primary Outcome: Device-related adverse events at 1-month follow-up post treatment [ Time Frame: 1-month post treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Peri-procedural Adverse Events at 1-month follow-up post treatment [ Time Frame: 1-month post treatment ]Incidence of peri-procedural Adverse Events at 1-month follow-up post treatment
- Device-related Adverse Events at 3 and 6 months follow-up post treatment [ Time Frame: 3 and 6 months post treatment ]Incidence of device-related Adverse Events at 3 and 6 months follow-up post treatment
- Reduction of average systolic daytime blood pressure assessed by 24h ABPM at 3-months [ Time Frame: 3 months post treatment ]Reduction of average systolic daytime blood pressure as assessed by 24h ambulatory blood pressure monitoring at 3-month compared to baseline
- Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment
- Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment
- Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment
Original Secondary Outcome: Same as current
Information By: Renal Dynamics GmbH
Dates:
Date Received: February 19, 2016
Date Started: April 2016
Date Completion: August 2017
Last Updated: May 10, 2016
Last Verified: May 2016