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

Not Applicable

Not yet recruiting

• Conditions: Essential Hypertension

• Registration Number: NCT06235554
• Lead Sponsor: Ceric Sàrl

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-22
• Last Update Submitted: 2024-01-22
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Study Start: 2024-02-20
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patient willing and able to comply with the protocol and has provided written informed consent.
• Age ≥18
• Patient candidate for renal denervation with the ParadiseTM System based on physician's assessment.
• Patients affiliated to a social security system

Exclusion Criteria

• Patients who meet any of the contraindications listed in the Instructions for Use of ParadiseTM Ultrasound Renal Denervation System will be excluded:

  • Renal arteries diameter < 3 mm and > 8 mm
  • Patient with relevant renal artery disease (% diameter stenosis > 30%, aneurysm or fibromuscular disease)
  • Stented renal artery
  • Iliac/femoral artery stenosis precluding insertion of the ParadiseTM catheter
  • Known allergy to contrast medium

• Patient with known secondary cause of hypertension

• Patient with contraindication to chronic anticoagulation therapy or heparin

• Patient with Type 1 diabetes mellitus

• Patient with more than one accessory renal artery

• Woman currently pregnant or breastfeeding

• Patient with other concomitant conditions that may adversely affect the patient or the study outcome

• Patient with mental or physical inability to participate in the study

• Patient under judicial protection, tutorship, or curatorship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
prevalence of occurrence of adverse events	Three month after procedure	safety of the renal nerves stimulation performed by Direct Wire Pacing technique during renal denervation procedure
efficacy on Systolic Blood Pressure change to be measured with a blood pressure monitor	Three month after procedure	efficacy of the renal nerves stimulation performed by Direct Wire Pacing technique during renal denervation procedure

Secondary Outcome Measures

Name	Time	Method
Impact on Systolic Blood Pressure	Three month after procedure	Investigate the impact of the renal denervation in the Renal Nerves Stimulation induced Systolic Blood Pressure change.
Systolic Blood Pressure as response prediction tool	Three month after procedure	Investigate whether Renal Nerves Stimulation induced Systolic Blood Pressure change before Renal Denervation could be a reliable tool to predict mid-term Renal Denervation response
Systolic Blood Pressure variation as response prediction tool	Three month after procedure	Investigate whether difference in Renal Nerves Stimulation-induced Systolic Blood Pressure change before and after Renal Denervation could be a reliable tool to predict mid-term Renal Denervation