ConfidenHT System for Diagnostic Electrical Mapping of Renal Nerves

NCT02777216 | Completed

• 1 other identifier: 167CLP
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

Brief Summary

To evaluate the safety and performance of the ConfidenHT System

Conditions

Hypertension

Keywords

RDN

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ConfidenHT system

EXPERIMENTAL

ConfidenHT system

Device: ConfidenHT system

Interventions

ConfidenHT system DEVICE

ConfidenHT Medical system

Also known as: ConfidenHT Medical system

ConfidenHT system

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BlueWind Medical: lead

Study Sites (3)

Hippocratio Hospital

Athens, Greece

Location

EMC

Rotterdam, Netherlands

Location

UMC

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kostas Tsioufis, MD

  Hippocratio Hospital, Athens, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 19, 2016
• Study Start: October 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 26, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); GR (1)