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

NCT06235554 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-02-01

No results posted yet for this study

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

PROCEDURE

Renal Stimulation

Renal Denervation procedure as per hospital routine practice

Sponsors & Collaborators

  • Electroducer

    collaborator INDUSTRY

  • Ceric Sàrl

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2024-07-01
Completion
2024-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06235554 on ClinicalTrials.gov