Status:
NOT_YET_RECRUITING
Continuous and Non-invasive Measurements by Task Force® CORE/CARDIO in Autonomic Function Testing (AFT)
Lead Sponsor:
CNSystems Medizintechnik GmbH
Conditions:
Autonomic Dysfunction
Orthostatic Intolerance
Eligibility:
All Genders
18+ years
Brief 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, Au...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05977335
Start Date
November 1 2025
End Date
December 1 2026
Last Update
May 13 2025
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