Clinical trial NCT05850741: Prospective Cardiac Ultrasound Imaging Study With Demonstrator
Official title: Prospective Cardiac Ultrasound Imaging Study With Demonstrator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: artificial intelligence
cardiac radioablation
echocardiography
motion monitoring
ventricular arrhythmia
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Image quality in terms of allowing a correct identification of the phase of the cardiac cycle by the prototype software.
timeFrame: Baseline
measure: Image quality in terms of allowing a correct measurement of the heart displacement (mainly due to respiratory motion) by the prototype software.
timeFrame: Baseline
measure: Image quality in terms of the ability to distinguish typical cardiac structures, as assessed visually by the clinical operator.
timeFrame: Baseline
measure: Image quality in terms of the stability of the image throughout the respiration cycle, as assessed visually by the clinical operator.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Roberto Rordorf, md
role: PRINCIPAL_INVESTIGATOR
References: