The goal of this feasibility study is to evaluate the safety and efficacy of the Renal Stimulation (RNS) by Direct Wire Pacing, during Renal Denervation (RDN) procedure in patient candidate for renal denervation with the ParadiseTM System. The main questions it aims to answer are:
- Is the RNS before RDN a straightforward method, allowing quantification of the renal sympathetic traffic?
- Does the RNS increase blood pressure (SBP), and is this increase significantly blunted after RDN?
- Does the 3-month 24h SBP decrease correlated with the RNS-induced SBP change before RDN?
- Can the difference between RNS-induced SBP rise before and after RDN be used as a procedural endpoint for RDN? Participants will be asked for their agreement to conduct an RNS before and after the RDN. No additional experimental procedure will be added to the standard of care.
Sponsor
Primary endpoints
- prevalence of occurrence of adverse events safety of the renal nerves stimulation performed by Direct Wire Pacing technique during renal denervation procedure [Time Frame: Three month after procedure]
- efficacy on Systolic Blood Pressure change to be measured with a blood pressure monitor efficacy of the renal nerves stimulation performed by Direct Wire Pacing technique during renal denervation procedure [Time Frame: Three month after procedure]
CERC Services
- EDC and data management
- Safety reporting
- Sites' contract management
- Study documents draft and review
Countries
France
Number of investigational sites
1 site in France
