Not Yet RecruitingNot Applicable

Continuous and Non-invasive Measurements by Task Force® CORE/CARDIO in Autonomic Function Testing (AFT)

75 participantsStarted 2026-11-01

Plain-language summary

Background: The investigational device, "Task Force® CORE" (TFC, CNSystems Medizintechnik GmbH, Graz, Austria) together with the "Task Force® CARDIO" (TFCARDIO, CNSystems Medizintechnik GmbH, Graz, Austria) medical device software, is a new CE-marked medical device for continuous non-invasive determination of blood pressure (BP), cardiac output (CO) and derived parameters based on the well established CNAP® (continuous non-invasive arterial pressure) technology by CNSystems. Aim: The primary aim of this prospective, method comparison, open study is data acquisition for the performance evaluation of the TFC during autonomic function testing in comparison with an clinically accepted reference method. Setting: The setting of the clinical investigation will be the autonomic function testing laboratory at the Department of Neurology, the University Hospital Center Zagreb. Inclusion criteria: Patients who are over 18 years and who provide written informed consent. Sample size: The study has an calculated sample size of 70 patients. Considering a drop-out rate of 5%, a total of 75 patients will be included. Statistics: Descriptive statistics, values for the percentage error and correlation estimates will be derived. Furthermore, scatterplot, Bland-Altman analysis, concordance analysis of parameter changes and further comparative statistics will be performed.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients (patients aged ≥ 18 years) * Patients giving written informed consent to participate in the study. * Patients with intact perfusion of both hands evidenced by a positive Allen's test. * Patients with orthostatic intolerance will be included Exclusion Criteria: * Patients with vascular implants at the sites of non-invasive BP measurement (fingers or upper arms) * Very low perfusion in the periphery * Arterial vascular diseases (arteriosclerosis, Raynaud's syndrome, endarteritis obliterans, collagenosis, severely advanced vascular diseases (PAOD)) * Patients with significant edema in the fingers * Patients with atrial fibrillation * Patients with valvular disease of grade 2 or above * Patients with ventricular assist devices * Subjects not passing the Allen's test for both hands. * Patients with a large lateral difference in BP (\> 15 mmHg for systolic BP and/or \>10 mmHg for diastolic BP) or with same arm measurement differences \> 10 mmHg in systolic or diastolic BP during assessment of lateral differences

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Agreement of blood pressure between investigational and reference device.

Timeframe: The agreement is calculated for the 5 minutes supine baseline period

Agreement of blood pressure between investigational and reference device.

Timeframe: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver

Agreement of blood pressure between investigational and reference device.

Timeframe: The agreement is calculated for 90 seconds Deep Breathing period

Agreement of blood pressure between investigational and reference device.

Timeframe: The agreement is calculated for 10 minutes head-up tilt table test period

Agreement of heart rate between investigational and reference device.

Timeframe: The agreement is calculated for the 5 minutes supine baseline period

Agreement of heart rate between investigational and reference device.

Timeframe: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver

Trial details

NCT IDNCT05977335

SponsorCNSystems Medizintechnik GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-06-01

Contact for this trial

Chief Technology Officer

00433167234560 office@cnsystems.com

View on ClinicalTrials.gov More Autonomic Dysfunction trials