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Updated: Jun 26, 2026

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Randomised, siteless study to compare systematic atrial fibrillation screening using enrichment by a risk prediction
Farzaneh Etminani1,2, Emma Sandgren3, Johan Holm4
1Center for Applied Intelligent Systems Research in Health (CAISR Health), Halmstad University, Halmstad, Sweden farzaneh.etminani@hh.se.
Insights
The CONSIDERING-AF study will assess if a risk prediction model improves atrial fibrillation (AF) detection in older adults. This screening approach aims to identify more AF cases for timely intervention and stroke prevention.
Area of Science:
- Cardiology
- Public Health
- Clinical Trials
Background:
- Atrial fibrillation (AF) is a prevalent arrhythmia linked to serious health risks like stroke and heart failure.
- Effective AF screening strategies are needed to identify at-risk populations and optimal detection methods.
Purpose of the Study:
- To evaluate the efficacy of a risk prediction model (RPM) combined with continuous ECG monitoring for detecting atrial fibrillation (AF).
- To compare AF screening enrichment using an RPM against standard care in individuals aged 65 and older.
Main Methods:
- A randomized, controlled, diagnostic superiority trial (CONSIDERING-AF) involving four parallel groups.
- Each group will include 740 individuals aged ≥65 years, with the intervention group receiving RPM-based screening and 14-day ECG patch monitoring.
- The primary outcome is incident AF recorded in a regional database over 6 months.
Main Results:
- The study is designed to determine if RPM-enriched screening increases AF detection rates compared to standard care.
- Secondary outcomes include comparing AF incidence across different screening and monitoring combinations and assessing oral anticoagulation treatment proportions.
Conclusions:
- The findings will inform optimal AF screening protocols for older adults.
- This research aims to improve early detection of AF, potentially reducing associated morbidity and mortality.
Introduction:
Atrial fibrillation (AF) is the most common arrhythmia and confers an increased risk of mortality, stroke, heart failure and cognitive decline. There is growing interest in AF screening; however, the most suitable population and device for AF detection remains to be elucidated. Here, we present the design of the CONSIDERING-AF (deteCtiON and Stroke preventIon by moDEl scRreenING for Atrial Fibrillation) study.
Methods And Analysis:
CONSIDERING-AF is a randomised, controlled, siteless, non-blinded diagnostic superiority trial with four parallel groups and a primary endpoint of identifying AF during a 6-month study period set in Region Halland, Sweden. In each group, 740 individuals aged≥65 years will be included. The primary objective is to compare the intervention of AF screening enrichment using a risk prediction model (RPM), followed by 14 days of a continuous ECG patch, with no intervention (standard care). Primary outcome is defined as the incident AF recorded in the Region Halland Information Database after 6 months as compared with standard care. Secondary endpoints include the difference in incident AF between groups enriched or not by the RPM, with and without an invitation to 14 days of continuous ECG recording, and the proportions of oral anticoagulation treatment in the four groups.
Ethics And Dissemination:
This study has ethical approval from the Swedish Ethical Review Authority. Results will be published in peer-reviewed international journals.
Trial Registration Number:
NCT05838781.
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