To gather electrocardiogram, pulse oximeter and heart rate analog front-end, accelerometer and temperature data of patients undergoing electrical carioversion (ECV) for the treatment of AF, and to use the data for the training and validation of Afi…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Validation of the algorithm will result in the calculation of four statistical
values. The sensitivity, specificity, F1-score and accuracy of the algorithm
will be determined. These values form the outcome of the study.
Secondary outcome
N.a.
Background summary
Atrial fibrillation (AF), the most common arrhythmia in Europa, requires better
and earlier detection than currently possible. By earlier detection, severe
consequences such as stroke and heart failure can be prevented. Afi, an
experimental physiological parameter monitor, is capable of monitoring patients
in a non-invasive manner and for a period of up to a month. In that way, even
paroxysmal AF can be detected and treated in a very early stage.
Study objective
To gather electrocardiogram, pulse oximeter and heart rate analog front-end,
accelerometer and temperature data of patients undergoing electrical
carioversion (ECV) for the treatment of AF, and to use the data for the
training and validation of Afi's AF detecting algorithm.
Study design
This research is a prospective, non-randomized, adjudicator-blinded
observational study. Afi will perform measurements 60 minutes before and 60
minutes after ECV on patients undergoing ECV for the treatment of AF. During
the ECV, Afi will be detached from the patient to prevent interference of the
device with the treatment. The collected data will be labeled after which part
of the data will be used for training the algorithm (66%) and the remaining
part will be used for the validation of the algorithm (33%).
Study burden and risks
This study is an observational trial which will be performed parallel to the
conventional ECV care. Therefore, no extra burden or risks are expected to be
associated with participation.
Reinier de Graafweg 5
Delft 2625AD
NL
Reinier de Graafweg 5
Delft 2625AD
NL
Listed location countries
Age
Inclusion criteria
>= 18 years
Hospitalized for electrical cardioversion to treat atrial fibrillation
Prepared to use an experimental monitoring device
Willing and competent to give written informed consent
Exclusion criteria
Implanted pacemaker, defibrillator or assist device
Other heart rhythm than atrial fibrillation or sinus rhythm
Skin lesions or scars around the midsternal line of the thorax
Tattoos around the midsternal line of the thorax
Known allergy to one of the sticker components of the device
Participation in another clinical trial
Already participated in trial 'Algorithm for Afi'
Pregnancy
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76708.058.21 |