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

Ceric Sàrl

Status: Not yet enrolling

Conditions: Essential Hypertension

Treatments: Procedure: Renal Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06235554

2023-A01789-36

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

intervention

Experimental group

Treatment:

Procedure: Renal Stimulation