ConfidenHT System for Diagnostic Electrical Mapping of Renal Nerves

Study Overview
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Brief Summary
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To evaluate the safety and performance of the ConfidenHT System

Detailed Description
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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

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Device: ConfidenHT system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ConfidenHT system<br>ConfidenHT system | Device: ConfidenHT system<br>* ConfidenHT Medical system<br>* Other names: ConfidenHT Medical system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of serious adverse events (system and/or procedure related events) | The incidence of serious adverse events (system and/or procedure related events) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RDN