NCT06235554

Feasibility Study Evaluating the Safety and Efficacy of the Renal Stimulation by Direct Wire Pacing, During Renal Denervation Procedure

Feasibility Study Evaluating the Safety and Efficacy of the Renal Stimulation by Direct Wire Pacing, During Renal Denervation Procedure.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Ceric Sàrl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
PROCEDURE	Renal Stimulation	Renal Denervation procedure as per hospital routine practice

Timeline

• Start date: 2024-02-20
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2024-02-01
• Last updated: 2024-02-01