An interventional study of Redy™ Renal Denervation System in Hypertension Resistant to Conventional Therapy, sponsored by Renal Dynamics GmbH. Status unknown at 10 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-05-11.
Sponsored by Renal Dynamics GmbH · Not applicable, Interventional, and Treatment
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.
This is the only study on the registry with Renal Dynamics GmbH as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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Exclusion criteria:
Renal Denervation System
Device: Redy™ Renal Denervation System
Renal Denervation System
Device-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
Plan to share: No
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This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Hypertension Resistant to Conventional Therapy