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RecruitingNCT06286358ARTIKUpdated May 1, 2026

Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK)

An observational study in Aortic Valve Disease and Aortic Aneurysm, sponsored by Université Libre de Bruxelles. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by Université Libre de Bruxelles · Observational

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
180
Ages
18 Years and older
Sex
All
01

Study summary

Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body surface.

The goal of this observational study is to learn about kinocardiography in patients with aortic valve disease (AVD) or thoracic aortic aneurysm (TAA). The investigators believe that this technology will enable to diagnose aortic valve disease and aortic aneurysm.

In patients with AVD of different severities or TAA, the investigators will collect informations from echocardiography and/or cardiac magnetic resonance imaging, KCG recordings, phonocardiography (PCG) recordings, and video recordings. Researchers will also compare subjects without any AVD nor TAA to better understand these effects on KCG, PCG and video signal.

Read the detailed description

Aortic valve disease (AVD) is a common but under-diagnosed disease which can cause various cardiovascular complications. AVD, including aortic stenosis and aortic regurgitation, can be associated with dilatation of the ascending thoracic aorta as a result of hemodynamic mechanisms and genetic predisposition. In the assessment of an AVD, it is important to consider if it is associated with a thoracic aortic aneurysm (TAA), and vice versa.

The prevalence of TAA in the general population is difficult to assess because most patients are asymptomatic, and their lethal complications (rupture and dissections) are often misdiagnosed as myocardial infarctions. The insidious evolution of aortic pathology motivates physicians to make the diagnosis as early as possible before the appearance of irreversible lesions causing significant morbidity and mortality. Traditional semiology can be useful for AVD screening (auscultation of a murmur, or observation of some visible semiological signs). However, it relies on the proficiency of care providers and may not allow a timely diagnosis of less severe forms of the disease. Moreover, imaging techniques used in current clinical practice are not appropriate for the organization of large-scale screening in asymptomatic patients. In addition, none of these techniques are accessible for the people living far away from a healthcare institution.

Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body surface. Signals are recorded thanks to a sensor placed on the sternum, another sensor placed on the lower back and electrocardiogram electrodes.

Smartphones are equipped with accelerometers and gyroscope, and may allow anyone to measure their own cardiac mechanical function similarly to KCG.

Phonocardiography (PCG) enables the detailed recording and analysis of heart sounds produced by the blood flow during the opening and closing of heart valves thanks to a microphone. It allows the extraction of heart sound information that reveals valvular diseases, such as the timing of heart valve closure, the frequency content of heart sounds, and the presence of diastolic or systolic murmurs.

Video image processing by Remote photoplethysmography (RPPG) or by Eulerian video magnification (EVM) allow the analysis of color changes and movements, invisible to the naked eye.

The primary objective of this prospective observational study is to better understand and assess KCG signals modifications due to aortic valve disease (AVD) and/or thoracic aortic aneurysm (TAA). It will be possible thanks to imaging techniques such as 4D flow MRI, and thanks to a comparison with PCG. The secondary objective of our study is to evaluate if a smartphone can be used for the diagnostic and characterization of AVD, using KCG, PCG or video image processing.

The possible participants will be identified, according to inclusion/exclusion criteria. Informed consent will be given to the patients. Immediately after the echocardiography and/or the cardiac MRI, the investigators will record KCG and PCG data, and then perform similar measurements using a smartphone placed on the torso. These measurements are followed by two short video recordings of 30 seconds, simultaneously to a KCG recording. For patients undergoing aortic valve replacement or thoracic aortic aneurysm surgery, the investigators will also perform the KCG measurements post-operatively, immediately after de post-operative cardiac MRI and/or echocardiography.

02

Conditions studied

  • Aortic Valve Disease
  • Aortic Aneurysm

Keywords

  • Aortic stenosis
  • Aortic regurgitation
  • Thoracic aortic aneurysm
  • Kinocardiography
03

In context

Aortic Valve Disease

234 studies on the registry are indexed under Aortic Valve Disease; 70 are open to participants now.

This study's planned enrollment of 180 is close to the median of 200 across 106 observational studies indexed under Aortic Valve Disease.

Browse Aortic Valve Disease studies →

Lead sponsor

Université Libre de Bruxelles is the lead sponsor of 45 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Both inpatients and outpatients may be included in "interventional treatment" group and "aortic valve disease of different severities" group.

"Control" group may include inpatients, outpatients and healthy subjects.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • "Interventional treatment" group

    • Adults (>18 y)
    • Interventional treatment indication for severe AVD and/or severe TAA, as decided by the Heart Team
  • "Aortic valve disease of different severities" group

    • Adults (>18y)
    • Aortic stenosis and/or aortic regurgitation and/or bicuspidy of different severities confirmed by echocardiography and/or cardiac MRI
  • "Control" group : - Adults (>18 y) appariated with the participants of other groups according to their age, sex, body surface area and

Exclusion criteria

Exclusion Criteria:

  • Any severe rhythm disorder such as frequent ventricular extrasystoles, atrial tachyarrhythmias
  • Subject's disabilty to give consent
  • Subjects suffering from aortic valve disease or thoracic aortic aneurysm will be excluded from the "control" group.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No

Groups and cohorts

  • Interventional treatment

    Patients with severe aortic valve disease or thoracic aortic aneurysm in whom interventional treatment has been previously decided by the Heart Team (i.e. the multidisciplinary team of cardiologists and cardiac surgeons treating the patient, independently of the research team) Patients with different severities of AVD or TAA, and healthy subjects. The KCG measurements and video recordings are consecutive to an echocardiography or cardiac MRI, and will be carried out in Erasme hospital.

    Diagnostic Test: Kinocardiography

  • Aortic valve disease of different severities

    Patients with aortic stenosis and/or aortic regurgitation and/or bicuspidy of different severities. The KCG measurements consecutive to the echocardiography and/or cardiac MRI will be carried out during their clinical management in Erasme hospital.

    Diagnostic Test: Kinocardiography

  • Control

    Subjects matched to the two other groups according to their age, gender, body surface area and left ventricular ejection fraction (LVEF), without AVD or TAA. The KCG measurements will be made immediately after the echocardiography and/or MRI in Erasme hospital.

    Diagnostic Test: Kinocardiography

Interventions

  • Diagnostic testKinocardiography

    Technology Measuring Cardiac Mechanical Activity Via Accelerometers and Gyroscopes

06

What researchers measure

Primary outcomes

  1. Understand and assess the complex mechanisms underlying the modifications of KCG signals in patients with AVD and/or TAA

    Correlation between KCG parameters and imaging parameters (echocardiography, 4D flow MRI)

    Time frame: 12 months

Secondary outcomes

  1. Comparing KCG to clinical assessment

    Correlation between KCG parameters, phonocardiography, semiological signs and video signals

    Time frame: 18 months

  2. Asses the clinical application of KCG to diagnose AVD and TAA

    With a dedicated device and with a smartphone

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Oct 2026, 30 months after the start.

Of 47 non-industry observational studies under Aortic Valve Disease, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 147. This study's planned 30 months is below that.

Counting every sponsor, half of 56 studies reached it within 49 months; a quarter within 23 and three quarters within 97.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2024
First posted
Feb 29, 2024
StartActual
Mar 7, 2024
Primary completionEst.
Oct 5, 2026
CompletionEst.
Dec 30, 2026
Last update
May 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06286358
Lead sponsor
Université Libre de Bruxelles
Responsible party
Elza Abdessater (Medical doctor at Erasme University Hospital, Erasme University Hospital) — Principal investigator
First posted
Feb 29, 2024
Start date
Mar 7, 2024
Primary completion
Oct 5, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
May 1, 2026

Study contacts

Elza Abdessater, MD
Contact
elza.abdessater@ulb.be
2 555 32 75 ext. +32
Philippe van de Borne, MD, PhD
Contact
philippe.vandeborne@hubruxelles.be
2 555 39 60 ext. +32

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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