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

Not Applicable

• Conditions: Hypertension Resistant to Conventional Therapy
• Interventions: Device: Redy™ Renal Denervation System

• Registration Number: NCT02690909
• Lead Sponsor: Renal Dynamics GmbH

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-24
• Study Start: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11
• Primary Completion: 2017-04
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Redy™ Renal Denervation System	Redy™ Renal Denervation System	Renal Denervation System

Primary Outcome Measures

Name	Time	Method
Device-related adverse events at 1-month follow-up post treatment	1-month post treatment	Incidence of device-related Adverse Events at 1-month follow-up post treatment

Secondary Outcome Measures

Name	Time	Method
Peri-procedural Adverse Events at 1-month follow-up post treatment	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	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	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	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	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	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

Trial Locations

Locations (10)

ZNA Middelheim Hospital; 🇧🇪 Antwerpen, Belgium

Saarland University Medical Center; 🇩🇪 Homburg, Germany

The Cardinal Stefan Wyszyński Institute of Cardiology; 🇵🇱 Warsaw, Poland

Academician E.N. Meshalkin Novosibirsk State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation

OLV Onze-Lieve-Vrouwziekenhuis; 🇧🇪 Aalst, Belgium

Kaplan Medical Center; 🇮🇱 Rehovot, Israel

KCS Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia

Galway University Hospital; 🇮🇪 Galway, Ireland

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Semmelweis University; 🇭🇺 Budapest, Hungary