Training and Validation of the Atrial Fibrillation Algorithm for Afi, a Novel Device for Arrythmia Diagnostics and Monitoring

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29538

Enrollment

166

Registered

2021-05-28

Start date

2021-06-21

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Interventions

Attaching Afi to the skin of the patient undergoing ECV, 60 minutes before ECV and 60 minutes after ECV

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Validation of AF detection algorithm	—

Contacts

Public ContactJan Constandse

Reinier de Graaf Gasthuis

j.constandse@rdgg.nl+31152603308

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)