NCT05977335

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: CNSystems Medizintechnik GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autonomic Dysfunction
• Orthostatic Intolerance

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Autonomic Function Testing	Autonomic Function Testing (AFT) includes Valsalva Manoever, Deep Breathing Test, and Head-up Tilt Table Testing.

Timeline

• Start date: 2026-11-01
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2023-08-04
• Last updated: 2026-03-18

Regulatory

• FDA-regulated device study