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

NCT06235554 | Unknown

• 1 other identifier: 2023-A01789-36
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Essential Hypertension

Keywords

Renal Stimulation; Renal Denervation procedure

Outcome Measures

Primary Outcomes (2)

• prevalence of occurrence of adverse events

  safety of the renal nerves stimulation performed by Direct Wire Pacing technique during renal denervation procedure

  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

  Three month after procedure

Secondary Outcomes (3)

• Impact on Systolic Blood Pressure

  Three month after procedure

• Systolic Blood Pressure as response prediction tool

  Three month after procedure

• Systolic Blood Pressure variation as response prediction tool

  Three month after procedure

Study Arms (1)

intervention

EXPERIMENTAL

Procedure: Renal Stimulation

Interventions

Renal Stimulation PROCEDURE

Renal Denervation procedure as per hospital routine practice

Also known as: Renal Dernervation

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ceric Sàrl: lead
• Electroducer: collaborator

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Feasibility study, prospective, open-label, single center, single-arm study

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 1, 2024
• Study Start: February 20, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01