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Not yet recruitingNCT06235554RNS by DWPUpdated Feb 1, 2024

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

An interventional study of Renal Stimulation in Essential Hypertension, sponsored by Ceric Sàrl. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-01.

Sponsored by Ceric Sàrl · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Essential Hypertension

Keywords

  • Renal Stimulation
  • Renal Denervation procedure
03

In context

Essential Hypertension

527 studies on the registry are indexed under Essential Hypertension; 76 are open to participants now.

This study's planned enrollment of 10 is below the median of 166 across 449 interventional studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Ceric Sàrl is the lead sponsor of 17 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    intervention

    Procedure: Renal Stimulation

Interventions

  • ProcedureRenal Stimulation

    Renal Denervation procedure as per hospital routine practice

    Also known as: Renal Dernervation

06

What researchers measure

Primary outcomes

  1. prevalence of occurrence of adverse events

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

    Time frame: Three month after procedure

  2. 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

    Time frame: Three month after procedure

Secondary outcomes

  1. Impact on Systolic Blood Pressure

    Investigate the impact of the renal denervation in the Renal Nerves Stimulation induced Systolic Blood Pressure change.

    Time frame: Three month after procedure

  2. 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

    Time frame: Three month after procedure

  3. 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

    Time frame: Three month after procedure

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06235554
Lead sponsor
Ceric Sàrl
Collaborators
Electroducer
Responsible party
Sponsor
First posted
Feb 1, 2024
Start date
Feb 20, 2024 (estimated)
Primary completion
Jul 1, 2024 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
Feb 1, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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