Clinical trial NCT06235554: Feasibility Study Evaluating the Safety and Efficacy of the Renal Stimulation by Direct Wire Pacing, During Renal Denervation Procedure
Official title: Feasibility Study Evaluating the Safety and Efficacy of the Renal Stimulation by Direct Wire Pacing, During Renal Denervation Procedure.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Essential Hypertension
Keywords: Renal Stimulation
Renal Denervation procedure
Lead sponsor: Ceric Sàrl
Sponsor class: INDUSTRY
Collaborators: name: Electroducer
First posted: 2024-02-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study, prospective, open-label, single center, single-arm study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: prevalence of occurrence of adverse events
timeFrame: Three month after procedure
measure: efficacy on Systolic Blood Pressure change to be measured with a blood pressure monitor
timeFrame: Three month after procedure
Secondary outcomes:
measure: Impact on Systolic Blood Pressure
timeFrame: Three month after procedure
measure: Systolic Blood Pressure as response prediction tool
timeFrame: Three month after procedure
measure: Systolic Blood Pressure variation as response prediction tool
timeFrame: Three month after procedure
Other outcomes:
Locations:
Study officials:
References: