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ConfidenHT System for Diagnostic Electrical Mapping of Renal Nerves (RDN)

B

BlueWind Medical

Status

Completed

Conditions

Hypertension

Treatments

Device: ConfidenHT system

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

To evaluate the safety and performance of the ConfidenHT System

Full 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

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

ConfidenHT system
Experimental group
Description:
ConfidenHT system
Treatment:
Device: ConfidenHT system

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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