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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Renal Denervation System
OLV Onze-Lieve-Vrouwziekenhuis
Aalst, Belgium
NOT_YET_RECRUITINGZNA Middelheim Hospital
Antwerp, Belgium
NOT_YET_RECRUITINGAsklepios Klinik St. Georg
Hamburg, Germany
NOT_YET_RECRUITINGSaarland University Medical Center
Homburg, Germany
NOT_YET_RECRUITINGSemmelweis University
Budapest, Hungary
NOT_YET_RECRUITINGGalway University Hospital
Galway, Ireland
NOT_YET_RECRUITINGKaplan Medical Center
Rehovot, Israel
RECRUITINGThe Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw, Poland
RECRUITINGAcademician E.N. Meshalkin Novosibirsk State Research Institute of Circulation Pathology
Novosibirsk, Russia
RECRUITINGKCS Clinical Center of Serbia
Belgrade, Serbia
NOT_YET_RECRUITINGDevice-related adverse events at 1-month follow-up post treatment
Incidence of device-related Adverse Events at 1-month follow-up post treatment
Time frame: 1-month post treatment
Peri-procedural Adverse Events at 1-month follow-up post treatment
Incidence of peri-procedural Adverse Events at 1-month follow-up post treatment
Time frame: 1-month post treatment
Device-related Adverse Events at 3 and 6 months follow-up post treatment
Incidence of device-related Adverse Events at 3 and 6 months follow-up post treatment
Time frame: 3 and 6 months post treatment
Reduction of average systolic daytime blood pressure assessed by 24h ABPM at 3-months
Reduction of average systolic daytime blood pressure as assessed by 24h ambulatory blood pressure monitoring at 3-month compared to baseline
Time frame: 3 months post treatment
Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment
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 diastolic 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
Blood pressure control to guideline recommended target blood pressure values 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
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