DIGITal mOnitoring afTer Af abLation

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 20, 2021

Primary Completion Date

July 1, 2023

Study Completion Date

August 15, 2023

Conditions
Atrial FibrillationAtrial Fibrillation RecurrentPVI
Interventions
DIAGNOSTIC_TEST

Digital Monitoring

Subjects will perform self-measurements with a PPG based smartphone application (FibriCheck™) to monitor for AF recurrence after the PVI procedure. One-minute measurements will be performed twice daily starting one month before the PVI procedure and continue up to 12 months after the procedure.

DIAGNOSTIC_TEST

Standard of care

Subjects will wear a 24-hour holter monitor at 3, 6 and 12 months after the PVI procedure. Additionally, outpatient cardiology clinic visits are organised at 6 weeks, 3 months and 12 months after the PVI procedure (including a 12-lead ECG and cardiologist consultation).

Trial Locations (1)

3600

Ziekenhuis Oost-Limburg, Genk

All Listed Sponsors
lead

Ziekenhuis Oost-Limburg

OTHER

NCT05486364 - DIGITal mOnitoring afTer Af abLation | Biotech Hunter | Biotech Hunter