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ID
Source
Brief title
Health condition
Atrial Fibrillation
Sponsors and support
Intervention
Outcome measures
Primary outcome
Validation of AF detection algorithm
Secondary outcome
N/A
Background summary
Afi is a novel AF detection device that is designed to improve AF monitoring and lower health care costs. Afi will use four different sensors and an AF detection algorithm to annotate AF episodes as a guideline for the physician. For the development of Afi’s algorithms, data must be gathered in a clinical setting for training and validation purposes. Patients who are hospitalized for electrical cardioversion (ECV) to treat AF will be monitored in two different health conditions within a single day: AF before ECV and sinus rhythm (SR) after ECV. This makes for a unique parallel comparison study population without the need for a long intensive follow-up.
Study objective
We hypothesize that our AF algorithm can detect AF events based upon the one-lead ECG data that Afi has collected with a sensitivity of 95% and a specificity of 80%.
Study design
Day of ECV, no follow-up
Intervention
Attaching Afi to the skin of the patient undergoing ECV, 60 minutes before ECV and 60 minutes after ECV
Inclusion criteria
≥ 18 years
Hospitalized for ECV to treat a priorly diagnosed AF
Prepared to use Afi
Willing and competent to give written IC
Exclusion criteria
Implanted pacemaker, defibrillator or assist device.
Other heart rhythms than AF or SR based upon conventional ECG
Skin lesions, scars, or tattoos around the midsternal line of the thorax
Known allergy to one of Afi’s or the sticker’s components
Participation in another clinical trial
Already participated in trial 'Algorithm for Afi'
Pregnancy
Design
Recruitment
IPD sharing statement
Plan description
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 |
|---|---|
| NTR-new | NL9501 |
| Other | METC Leiden Delft Den Haag : METC LDD P21.019 |