Prospective Cardiac Ultrasound Imaging Study With Demonstrator (CARDIOKIT)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Ventricular Tachycardia

Treatments: Device: Cardiokit

Study type: Interventional

Funder types: Other

Identifiers

NCT05850741

IRCCSSanMatteoPavia

Details and patient eligibility

About

The Prospective Cardiac Ultrasound Imaging Study is a single center, single arm, feasibility study. The study aims at collecting cardiac ultrasound data from patients diagnosed with ventricular tachycardia, during rest and short breath hold sequences. This study is part of the engineering studies linked to the CardioKit-Minimum Viable Product project. The CardioKit prototype used in the study can monitor cyclical heart-beat motion, cyclical respiratory motion and non-cyclical heart position changes while the patient is lying in supine position.

Full description

The research will analyse the ultrasound image data quality, especially investigating the ability of the prototype system to automatically and correctly interpret ultrasound images and artifact issues which may arise from age, body composition, mechanical valves, leads from implanted devices, or other implants. The study will establish if it is appropriate to develop a new medical device supporting automated cardiac ultrasound image interpretation during non-invasive cardiac procedures, i.e. ventricular tachycardia stereotactic radioablation. This early research protocol did collect data from 24 adult patients. The data were not used for diagnostic nor treatment purposes and the protocol's procedure duration was limited to one hour, hence the research was considered of very limited risk for the participants. The research will provide a Proof-of-Concept for a Medical Device to benefit patients with ventricular tachycardia and other cardiac pathologies in the future.

Enrollment: 24 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient with history of ventricular tachycardia
2. Over 18 years old
3. Ability and willingness to provide written informed consent

Exclusion criteria

1. Patient in arrhythmic storm

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Device

Experimental group

Description:

The following procedure steps will take place: * The study system is installed in the room before patient arrival * The patient needs to fully undress the upper body before lying on the bed * The 3 ECG electrodes are placed * Ultrasound gel is applied on the ultrasound probe

Treatment:

Device: Cardiokit