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

Essential Hypertension Clinical Trial

— RNS by DWP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06235554
• Other study ID #: 2023-A01789-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: Ceric Sàrl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension

Intervention

Procedure:
• Renal Stimulation
Renal Denervation procedure as per hospital routine practice

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ceric Sàrl	Electroducer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Impact on Systolic Blood Pressure	Investigate the impact of the renal denervation in the Renal Nerves Stimulation induced Systolic Blood Pressure change.	Three month after procedure
Secondary	Systolic Blood Pressure as response prediction tool	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	Three month after procedure
Secondary	Systolic Blood Pressure variation as response prediction tool	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	Three month after procedure