Skip to content

Personalized approach using wearable technology for early detection of Atrial Fibrillation (PATCH-AF)

Personalized approach using wearable technology for early detection of Atrial Fibrillation (PATCH-AF) - PATCH-AF study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54154
Enrollment
930
Registered
2021-07-09
Start date
2021-10-08
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

arrhythmia Atrial fibrillation

Interventions

7-day ECG- monitoring using the Bittium Faros 360 at baseline (t=0), after one(t=1) and two years (t=2).

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
65 Years to 99 Years

Inclusion criteria

Inclusion criteria: Aged 65 and over Not diagnosed with atrial fibrillation CHA2SD2VASc score of 4 or more for women and 3 or more for men

Exclusion criteria

Exclusion criteria: Legal incompetence Pacemaker/ICD

Design outcomes

Primary

MeasureTime frame
The main study parameter will be the difference in the number of patients with newly found AF between the intervention and control arms over three years of follow-up.

Secondary

MeasureTime frame
1. Difference in incident AF yield between the screened patients in the interventionarm and all patients in control arms 2. Difference in time to diagnosis of AF between intervention and control practices. 3. Difference in other relevant cardiovascular outcomes like stroke, TIA, dementia, heart failure and use of anticoagulation therapy. 4. Difference in detection of new AF in control practices participating in the trial versus detection of AF in non-participating general practices in the network. 5. Patient experience with the monitoring device in the intervention group and how they think about the implementation of AF screening in the future.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)