Prospective Cardiac Ultrasound Imaging Study With Demonstrator (CARDIOKIT)

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Device: Cardiokit

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • IRCCS Policlinico San Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device; 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	Device: Cardiokit; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image quality in terms of allowing a correct identification of the phase of the cardiac cycle by the prototype software.	The primary endpoint was defined as the percentage of patients able to obtain a positive result in a multi parametric score of image quality, consisting of: Score = 1: average phase error per patient, defined as the difference between the phase of the cardiac cycle identified by the algorithm and the one evaluated by the ECG reference <0.1. Score = 0: average phase error per patient ≥0.1. For each patient, scoring was done for each imaging view (i.e., parasternal and apical). If the score was 2 (at least 1 point in A or B and 1 point in C or D) or greater for at least one of the imaging views, the outcome was considered as positive. The final result is the proportion of patients (in %) with a positive outcome, defined as the number of patients with a positive evaluation divided by the total number of patients x 100.	Baseline
Image quality in terms of allowing a correct measurement of the heart displacement (mainly due to respiratory motion) by the prototype software.	The primary endpoint was defined as the percentage of patients able to obtain a positive result in a multi parametric score of image quality, consisting of: Score = 1: maximum excursion calculated by the algorithm <30 mm with a total 3D error in the calculation of the displacement <3 mm. Score = 0: either maximum excursion calculated by the algorithm ≥30 mm or total 3D error in the calculation of the displacement ≥3 mm (or both). For each patient, scoring was done for each imaging view (i.e., parasternal and apical). If the score was 2 (at least 1 point in A or B and 1 point in C or D) or greater for at least one of the imaging views, the outcome was considered as positive. The final result is the proportion of patients (in %) with a positive outcome, defined as the number of patients with a positive evaluation divided by the total number of patients x 100.	Baseline
Image quality in terms of the ability to distinguish typical cardiac structures, as assessed visually by the clinical operator.	The primary endpoint was defined as the percentage of patients able to obtain a positive result in a multi parametric score of image quality, consisting of: Score = 1: ability to identify visually by an experienced operator in the acquired image at least one of the following structures: left ventricular free wall, interventricular septum, mitral valve, or aortic valve. Score = 0: inability to identify at least one of these structures. For each patient, scoring was done for each imaging view (i.e., parasternal and apical). If the score was 2 (at least 1 point in A or B and 1 point in C or D) or greater for at least one of the imaging views, the outcome was considered as positive. The final result is the proportion of patients (in %) with a positive outcome, defined as the number of patients with a positive evaluation divided by the total number of patients x 100.	Baseline
Image quality in terms of the stability of the image throughout the respiration cycle, as assessed visually by the clinical operator.	The primary endpoint was defined as the percentage of patients able to obtain a positive result in a multi parametric score of image quality, consisting of: Score = 1: persistence of cardiac structures within the echocardiographic image during respiratory motion. Score = 0: disappearance of cardiac structures from the echocardiographic image during respiratory motion. For each patient, scoring was done for each imaging view (i.e., parasternal and apical). If the score was 2 (at least 1 point in A or B and 1 point in C or D) or greater for at least one of the imaging views, the outcome was considered as positive. The final result is the proportion of patients (in %) with a positive outcome, defined as the number of patients with a positive evaluation divided by the total number of patients x 100.	Baseline

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
• Investigators: Principal Investigator: Roberto Rordorf, md, Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2021
• Primary Completion (Actual): July 5, 2021
• Study Completion (Actual): February 3, 2022

Study Registration Dates

• First Submitted: April 29, 2023
• First Submitted That Met QC Criteria: April 29, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: echocardiography; artificial intelligence; ventricular arrhythmia; cardiac radioablation; motion monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: IRCCSSanMatteoPavia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No