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%.
ID
Bron
Verkorte titel
Aandoening
Atrial Fibrillation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Validation of AF detection algorithm
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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%.
Onderzoeksopzet
Day of ECV, no follow-up
Onderzoeksproduct en/of interventie
Attaching Afi to the skin of the patient undergoing ECV, 60 minutes before ECV and 60 minutes after ECV
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
≥ 18 years
Hospitalized for ECV to treat a priorly diagnosed AF
Prepared to use Afi
Willing and competent to give written IC
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9501 |
| Ander register | METC Leiden Delft Den Haag : METC LDD P21.019 |