ConfidenHT System for Diagnostic Electrical Mapping of Renal Nerves
NCT ID: NCT02777216
Last Updated: 2018-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2016-10-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ConfidenHT system
ConfidenHT system
ConfidenHT system
ConfidenHT Medical system
Interventions
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ConfidenHT system
ConfidenHT Medical system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \>18 years and \<75.
3. Either:
1. Hypertensive patients planned to undergo elective cardiac catheterization
2. Potential candidates for renal sympathetic denervation
4. Main renal artery with diameter ≥ 4.0mm.
5. Glomerular Filtration Rate (GFR) \>45 mL/min
6. A patient who is mentally competent with the ability to understand and comply with the requirements of the study.
7. The patient agrees to attend all follow-up evaluations and is willing to complete required exams and tests.
8. 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
2. Relevant renal artery disease (% diameter stenosis\>30%, aneurysm or fibromuscular dysplasia).
3. Known secondary causes of hypertension.
4. The patient has a life expectancy ≤ 12 months.
5. The patient has undergone prior renal denervation, renal stenting, and/or abdominal aortic stent grafts.
6. The patient has chronic oxygen use other than nocturnal support for sleep apnea.
7. The patient has type I diabetes mellitus.
8. The patient has had a previous organ transplant or is awaiting a renal transplant.
9. Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator).
10. The patient has triple ipsilateral artery ostia.
11. Moderate to severe valvular heart disease.
12. The patient has other concomitant conditions that may adversely affect the patient or the study outcome.
13. Female who is pregnant, nursing or planning to become pregnant.
14. Documented contraindication or allergy to contrast medium not amenable to treatment.
18 Years
75 Years
ALL
No
Sponsors
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BlueWind Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Kostas Tsioufis, MD
Role: PRINCIPAL_INVESTIGATOR
Hippocratio Hospital, Athens, Greece
Locations
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Hippocratio Hospital
Athens, , Greece
EMC
Rotterdam, , Netherlands
UMC
Utrecht, , Netherlands
Countries
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Other Identifiers
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167CLP
Identifier Type: -
Identifier Source: org_study_id
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