Essential HypertensionRNS by DWPNCT06235554
Feasibility Study Evaluating the Safety and Efficacy of the Renal Stimulation by Direct Wire Pacing, During Renal Denervation Procedure
A study testing Renal Stimulation in people with Essential Hypertension, run by Ceric Sàrl.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Renal Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2024to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Official title: Feasibility Study Evaluating the Safety and Efficacy of the Renal Stimulation by Direct Wire Pacing, During Renal Denervation Procedure.
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.
- Conditions
- Essential Hypertension
- Being tested
- Renal Stimulation
- Keywords
- Renal Stimulation, Renal Denervation procedure
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal StimulationProcedure or surgery
Also called Renal Dernervation
Renal Denervation procedure as per hospital routine practice
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Not described Receives: Procedure: Renal Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of occurrence of adverse events
safety of the renal nerves stimulation performed by Direct Wire Pacing technique during renal denervation procedure
Measured: Three month after procedure
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
Measured: Three month after procedure
Secondary outcomes (3)
Impact on Systolic Blood Pressure
Investigate the impact of the renal denervation in the Renal Nerves Stimulation induced Systolic Blood Pressure change.
Measured: Three month after procedure
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
Measured: Three month after procedure
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
Measured: Three month after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start20 Feb 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Ceric SàrlThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study, prospective, open-label, single center, single-arm study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceric Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Electroducer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235554
- Sponsor's protocol ID
- 2023-A01789-36
- Acronym
- RNS by DWP
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Evaluating the Safety and Efficacy of the Renal Stimulation by Direct Wire Pacing, During Renal Denervation Procedure.
- ClinicalTrials.gov ID
- NCT06235554
- Acronym / sponsor ID
- RNS by DWP / 2023-A01789-36
- Conditions
- Essential Hypertension
- Keywords
- Renal Stimulation, Renal Denervation procedure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ceric SàrlIndustry (pharma, biotech, devices)
- Collaborators
- Electroducer
- Study start
- 20 Feb 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study, prospective, open-label, single center, single-arm study
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Procedure: Renal Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Patients who meet any of the contraindications listed in the Instructions for Use of ParadiseTM Ultrasound Renal Denervation System will be excluded:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal StimulationAlso: Renal DernervationRenal Denervation procedure as per hospital routine practice | Procedure or surgery | intervention |
Primary outcome
prevalence of occurrence of adverse events
Time frame: Three month after procedure
safety of the renal nerves stimulation performed by Direct Wire Pacing technique during renal denervation procedure
efficacy on Systolic Blood Pressure change to be measured with a blood pressure monitor
Time frame: Three month after procedure
efficacy of the renal nerves stimulation performed by Direct Wire Pacing technique during renal denervation procedure
3 secondary outcomes
Impact on Systolic Blood Pressure
Time frame: Three month after procedure
Systolic Blood Pressure as response prediction tool
Time frame: Three month after procedure
Systolic Blood Pressure variation as response prediction tool
Time frame: Three month after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Renal Stimulation in people with Essential Hypertension, run by Ceric Sàrl.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of occurrence of adverse events (time frame: Three month after procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.