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

March 16, 2026 updated by: CNSystems Medizintechnik GmbH

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who present at the Referral Center for Autonomic Nervous System of the University Hospital Center Zagreb referred to autonomous nervous system testing will be included.

Description

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Orthostatic Intolerance Patients
Diagnostic test: Autonomic Function Testing
Autonomic Function Testing (AFT) includes Valsalva Manoever, Deep Breathing Test, and Head-up Tilt Table Testing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Agreement of blood pressure between investigational and reference device.
Time Frame: The agreement is calculated for the 5 minutes supine baseline period
The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
The agreement is calculated for the 5 minutes supine baseline period
Agreement of blood pressure between investigational and reference device.
Time Frame: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
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.
Time Frame: The agreement is calculated for 90 seconds Deep Breathing period
The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
The agreement is calculated for 90 seconds Deep Breathing period
Agreement of blood pressure between investigational and reference device.
Time Frame: The agreement is calculated for 10 minutes head-up tilt table test period
The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
The agreement is calculated for 10 minutes head-up tilt table test period
Agreement of heart rate between investigational and reference device.
Time Frame: The agreement is calculated for the 5 minutes supine baseline period
The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
The agreement is calculated for the 5 minutes supine baseline period
Agreement of heart rate between investigational and reference device.
Time Frame: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
Agreement of heart rate between investigational and reference device.
Time Frame: The agreement is calculated for 90 seconds Deep Breathing period
The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
The agreement is calculated for 90 seconds Deep Breathing period
Agreement of heart rate between investigational and reference device.
Time Frame: The agreement is calculated for 10 minutes head-up tilt table test period
The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
The agreement is calculated for 10 minutes head-up tilt table test period
Agreement of cardiac output between investigational and reference device.
Time Frame: The agreement is calculated for the 5 minutes supine baseline period
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
The agreement is calculated for the 5 minutes supine baseline period
Agreement of cardiac output between investigational and reference device.
Time Frame: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
Agreement of cardiac output between investigational and reference device.
Time Frame: The agreement is calculated for 90 seconds Deep Breathing period
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
The agreement is calculated for 90 seconds Deep Breathing period
Agreement of cardiac output between investigational and reference device.
Time Frame: The agreement is calculated for 10 minutes head-up tilt table test period
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
The agreement is calculated for 10 minutes head-up tilt table test period

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CNSystems Medizintechnik GmbH

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AFTs Task Force® CORE/CARD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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