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

Status

Completed

Conditions

Intervention / Treatment

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

  • Greece
      • Athens, Greece
        • Hippocratio Hospital
  • Netherlands
      • Rotterdam, Netherlands
        • EMC
      • Utrecht, Netherlands
        • UMC

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:

  1. Signed written informed consent.
  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:

  1. Previous participation in another study with any investigational drug or device within the past 30 days.
  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.

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
Experimental: ConfidenHT system
Device: ConfidenHT system
ConfidenHT Medical system
Other Names:
  • ConfidenHT Medical system

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)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BlueWind Medical

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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