- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02777216
ConfidenHT System for Diagnostic Electrical Mapping of Renal Nerves (RDN)
February 22, 2018 updated by: BlueWind Medical
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
Study Overview
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Athens, Greece
- Hippocratio Hospital
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Rotterdam, Netherlands
- EMC
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Utrecht, Netherlands
- UMC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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
Exclusion criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ConfidenHT system
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ConfidenHT Medical system
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kostas Tsioufis, MD, Hippocratio Hospital, Athens, Greece
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
November 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
May 17, 2016
First Submitted That Met QC Criteria
May 17, 2016
First Posted (Estimate)
May 19, 2016
Study Record Updates
Last Update Posted (Actual)
February 26, 2018
Last Update Submitted That Met QC Criteria
February 22, 2018
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 167CLP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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