Prospective Cardiac Ultrasound Imaging Study With Demonstrator

NCT ID: NCT05850741

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-04
• Study Completion Date: 2022-02-03

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.

Conditions

Ventricular Tachycardia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Cardiokit

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Roberto Rordorf

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Rordorf, md

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Policlinico San Matteo di Pavia

Locations

IRCCS Policlinico San Matteo

Pavia, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IRCCSSanMatteoPavia

Identifier Type: -

Identifier Source: org_study_id