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

Launched by CNSYSTEMS MEDIZINTECHNIK GMBH · Jul 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called Task Force® CORE, which is designed to measure important heart and blood pressure information without needing any invasive procedures. The goal is to see how well this device works for patients with autonomic dysfunction and orthostatic intolerance—conditions that affect the body's ability to regulate blood pressure and heart rate, especially when standing up. The study will take place at the University Hospital Center Zagreb, and will involve about 75 adult participants who provide consent to join.

To be eligible for the trial, participants must be at least 18 years old and have good blood flow in both hands, as confirmed by a simple test. They will be monitored while undergoing tests that assess their autonomic function. However, people with certain health conditions, such as severe vascular diseases or specific heart issues, will not be able to participate. Those who join can expect to help evaluate a promising new tool that could improve how doctors track and manage conditions related to autonomic function.

Gender

ALL

Eligibility criteria

• 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