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

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: Not yet recruiting
• Conditions: Orthostatic Intolerance; Autonomic Dysfunction
• Intervention / Treatment: Diagnostic test: Autonomic Function Testing

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Chief Technology Officer; Phone Number: 00433167234560; Email: office@cnsystems.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Agreement of blood pressure between investigational and reference device.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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

• Sponsor: CNSystems Medizintechnik GmbH

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Blood Pressure; Hemodynamics; Non-invasive; Continuous; Autonomic Function Testing
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Autonomic Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Primary Dysautonomias; Orthostatic Intolerance
• Other Study ID 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