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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06235554
Other study ID # 2023-A01789-36
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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