Ventricular TachycardiaCARDIOKITNCT05850741
Prospective Cardiac Ultrasound Imaging Study With Demonstrator
A study testing Cardiokit in people with Ventricular Tachycardia, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Cardiokit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jun 2021to 3 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with history of ventricular tachycardia
- Over 18 years old
- Ability and willingness to provide written informed consent
Who cannot join
- 1. Patient in arrhythmic storm
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Cardiokit
- Keywords
- artificial intelligence, cardiac radioablation, echocardiography, motion monitoring, ventricular arrhythmia
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiokitDevice
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 group | Role | What they receive |
|---|---|---|
| Device | Experimental | 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 Receives: Device: Cardiokit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start4 Jun 2021
- Primary completion5 Jul 2021
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Rordorf, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Roberto Rordorf, md, Principal investigator, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850741
- Sponsor's protocol ID
- IRCCSSanMatteoPavia
- Acronym
- CARDIOKIT
- Status last verified
- May 2023
- First submitted
- 29 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cardiac Ultrasound Imaging Study With Demonstrator
- ClinicalTrials.gov ID
- NCT05850741
- Acronym / sponsor ID
- CARDIOKIT / IRCCSSanMatteoPavia
- Conditions
- Ventricular Tachycardia
- Keywords
- artificial intelligence, cardiac radioablation, echocardiography, motion monitoring, ventricular arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: CardiokitThe 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with history of ventricular tachycardia
- Over 18 years old
- Ability and willingness to provide written informed consent
Key exclusion criteria (1 listed)
- 1. Patient in arrhythmic storm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardiokitThe 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. | Device | Device |
Primary outcome
Image quality in terms of allowing a correct identification of the phase of the cardiac cycle by the prototype software.
Time frame: Baseline
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.
Image quality in terms of allowing a correct measurement of the heart displacement (mainly due to respiratory motion) by the prototype software.
Time frame: Baseline
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.
Image quality in terms of the ability to distinguish typical cardiac structures, as assessed visually by the clinical operator.
Time frame: Baseline
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.
Image quality in terms of the stability of the image throughout the respiration cycle, as assessed visually by the clinical operator.
Time frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Rordorf, md principal investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiokit in people with Ventricular Tachycardia, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality in terms of allowing a correct identification of the phase of the cardiac cycle by the prototype software. (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.