HypertensionRDNNCT02777216
ConfidenHT System for Diagnostic Electrical Mapping of Renal Nerves
A study testing ConfidenHT system in people with Hypertension, run by BlueWind Medical at 3 sites in 2 countries.
Trial summary
To evaluate the safety and performance of the ConfidenHT System Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- ConfidenHT system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2016to Dec 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Age >18 years and <75.
- Either:
- Hypertensive patients planned to undergo elective cardiac catheterization
- Potential candidates for renal sympathetic denervation
- Main renal artery with diameter ≥ 4.0mm.
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- Glomerular Filtration Rate (GFR) >45 mL/min
- A patient who is mentally competent with the ability to understand and comply with the requirements of the study.
- The patient agrees to attend all follow-up evaluations and is willing to complete required exams and tests.
- Female patients with childbearing potential must agree:
- to use a valid method of contraception (oral contraceptives, intrauterine device, subcutaneous contraceptive implant, vaginal ring)
- to perform a pregnancy test
Who cannot join
- Previous participation in another study with any investigational drug or device within the past 30 days.
- Relevant renal artery disease (% diameter stenosis>30%, aneurysm or fibromuscular dysplasia).
- Known secondary causes of hypertension.
- The patient has a life expectancy ≤ 12 months.
- The patient has undergone prior renal denervation, renal stenting, and/or abdominal aortic stent grafts.
- The patient has chronic oxygen use other than nocturnal support for sleep apnea.
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- The patient has type I diabetes mellitus.
- The patient has had a previous organ transplant or is awaiting a renal transplant.
- Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator).
- The patient has triple ipsilateral artery ostia.
- Moderate to severe valvular heart disease.
- The patient has other concomitant conditions that may adversely affect the patient or the study outcome.
- Female who is pregnant, nursing or planning to become pregnant.
- Documented contraindication or allergy to contrast medium not amenable to treatment.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: ConfidenHTTM System Safety and Performance of Diagnostic Electrical Mapping of Renal Nerves in Hypertensive Patients and/or Potential Candidates for a Renal Sympathetic Denervation (RDN) Procedure
To evaluate the safety and performance of the ConfidenHT System
Read the detailed description
To evaluate the safety and performance of the ConfidenHT System for diagnostic mapping of renal nerves; functional distribution of renal nerves and the effect of renal nerve stimulation on the blood pressure
- Conditions
- Hypertension
- Being tested
- ConfidenHT system
- Keywords
- RDN
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConfidenHT systemDevice
Also called ConfidenHT Medical system
ConfidenHT Medical system
| Study group | Role | What they receive |
|---|---|---|
| ConfidenHT system | Experimental | ConfidenHT system Receives: Device: ConfidenHT system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of serious adverse events (system and/or procedure related events)
The incidence of serious adverse events (system and/or procedure related events)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BlueWind Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kostas Tsioufis, MD, Principal investigator, Hippocratio Hospital, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777216
- Sponsor's protocol ID
- 167CLP
- Acronym
- RDN
- Status last verified
- Dec 2017
- First submitted
- 17 May 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ConfidenHTTM System Safety and Performance of Diagnostic Electrical Mapping of Renal Nerves in Hypertensive Patients and/or Potential Candidates for a Renal Sympathetic Denervation (RDN) Procedure
- ClinicalTrials.gov ID
- NCT02777216
- Acronym / sponsor ID
- RDN / 167CLP
- Conditions
- Hypertension
- Keywords
- RDN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BlueWind MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 May 2016 (estimated)
- 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.
To evaluate the safety and performance of the ConfidenHT System
Detailed description
To evaluate the safety and performance of the ConfidenHT System for diagnostic mapping of renal nerves; functional distribution of renal nerves and the effect of renal nerve stimulation on the blood pressure
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ConfidenHT system | Experimental | Device: ConfidenHT systemConfidenHT system |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed written informed consent.
- Age >18 years and <75.
- Either:
- Main renal artery with diameter ≥ 4.0mm.
- Glomerular Filtration Rate (GFR) >45 mL/min
Key exclusion criteria (14 listed)
- Previous participation in another study with any investigational drug or device within the past 30 days.
- Relevant renal artery disease (% diameter stenosis>30%, aneurysm or fibromuscular dysplasia).
- Known secondary causes of hypertension.
- The patient has a life expectancy ≤ 12 months.
- The patient has undergone prior renal denervation, renal stenting, and/or abdominal aortic stent grafts.
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 |
|---|---|---|
| ConfidenHT systemAlso: ConfidenHT Medical systemConfidenHT Medical system | Device | ConfidenHT system |
Primary outcome
The incidence of serious adverse events (system and/or procedure related events)
Time frame: 3 months
The incidence of serious adverse events (system and/or procedure related events)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Kostas Tsioufis, MD principal investigator
Hippocratio Hospital, Athens, Greece
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ConfidenHT system in people with Hypertension, run by BlueWind Medical at 3 sites in 2 countries.
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 12 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: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of serious adverse events (system and/or procedure related events) (time frame: 3 months). 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 26 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.