Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564012
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Wearable Cardiac Monitor to Enhance Detection of Arrhythmia Recurrence After Catheter Ablation of Atrial Fibrillation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Wearable Cardiac Monitor to Enhance Detection of Arrhythmia Recurrence After Catheter Ablation of Atrial Fibrillation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WEAR-AF
Brief Summary:
The WEAR-AF study is a prospective multicenter clinical trial designed to evaluate the efficacy of wearable technology in the detection monitoring and management of atrial fibrillation AF This study aims to assess how wearable devices such as smartwatches equipped with electrocardiogram ECG capabilities can be used to identify AF episodes guide treatment decisions and ultimately improve patient outcomes
Participants will be individuals diagnosed with or at high risk for atrial fibrillation The study will track the accuracy of AF detection patient adherence to monitoring and the impact on clinical outcomes including stroke prevention symptom management and quality of life
The findings from WEAR-AF are expected to contribute to the growing body of evidence supporting the integration of wearable technology into routine clinical practice for AF management offering insights into its potential to enhance patient care and reduce healthcare costs
Participants will be individuals diagnosed with or at high risk for atrial fibrillation The study will track the accuracy of AF detection patient adherence to monitoring and the impact on clinical outcomes including stroke prevention symptom management and quality of life
The findings from WEAR-AF are expected to contribute to the growing body of evidence supporting the integration of wearable technology into routine clinical practice for AF management offering insights into its potential to enhance patient care and reduce healthcare costs
Detailed Description:
Study Description
The WEAR-AF study is a prospective multicenter clinical trial designed to evaluate the effectiveness and clinical utility of wearable technology in the detection monitoring and management of atrial fibrillation AF This study seeks to understand how wearable devices particularly those with electrocardiogram ECG capabilities can be integrated into routine clinical practice to enhance the early detection and continuous monitoring of AF a common and potentially serious cardiac arrhythmia
Background and Rationale
Atrial fibrillation is a significant public health issue associated with increased risks of stroke heart failure and other cardiovascular complications Current guidelines emphasize the importance of early detection and continuous monitoring of AF to manage symptoms and prevent complications effectively Wearable technology such as smartwatches and fitness trackers equipped with ECG functions has emerged as a promising tool for real-time AF detection and monitoring However the clinical efficacy accuracy and patient adherence associated with these devices require further investigation
Objectives
The primary objective of the WEAR-AF study is to evaluate the diagnostic accuracy of wearable ECG devices in detecting AF episodes compared to standard clinical practices such as Holter monitoring and traditional ECGs Secondary objectives include assessing the impact of continuous AF monitoring on clinical outcomes including stroke prevention symptom management and patient quality of life The study will also examine patient adherence to the use of wearable technology and its influence on healthcare utilization and costs
Study Design
WEAR-AF is a prospective observational study that will enroll participants across multiple centers Eligible participants include individuals diagnosed with AF or those at high risk for developing AF Participants will be provided with wearable devices equipped with ECG capabilities and will be monitored over a specified period The study will compare the AF detection rates of these wearable devices against standard diagnostic tools evaluate the consistency of AF management with the wearable devices data and document any changes in clinical outcomes over time
Endpoints
Primary Endpoint
Diagnostic accuracy of wearable ECG devices in detecting AF compared to standard methods
Secondary Endpoints
Impact of wearable ECG monitoring on stroke incidence and other cardiovascular events
Changes in AF-related symptoms and quality of life as measured by validated questionnaires
Patient adherence to the use of wearable technology for continuous AF monitoring
Healthcare utilization and cost-effectiveness analysis
Significance
The WEAR-AF study aims to generate robust evidence on the role of wearable technology in managing AF By providing insights into the accuracy utility and patient adherence to these devices the study will contribute to the development of guidelines for the integration of wearable technology into clinical practice The ultimate goal is to improve patient outcomes by enabling more timely and precise management of AF
Conclusion
The WEAR-AF study will explore the potential of wearable technology to transform the management of atrial fibrillation Through this research we aim to provide valuable data on the effectiveness of wearable ECG devices in real-world settings offering a foundation for future innovations in digital health and personalized medicine
The WEAR-AF study is a prospective multicenter clinical trial designed to evaluate the effectiveness and clinical utility of wearable technology in the detection monitoring and management of atrial fibrillation AF This study seeks to understand how wearable devices particularly those with electrocardiogram ECG capabilities can be integrated into routine clinical practice to enhance the early detection and continuous monitoring of AF a common and potentially serious cardiac arrhythmia
Background and Rationale
Atrial fibrillation is a significant public health issue associated with increased risks of stroke heart failure and other cardiovascular complications Current guidelines emphasize the importance of early detection and continuous monitoring of AF to manage symptoms and prevent complications effectively Wearable technology such as smartwatches and fitness trackers equipped with ECG functions has emerged as a promising tool for real-time AF detection and monitoring However the clinical efficacy accuracy and patient adherence associated with these devices require further investigation
Objectives
The primary objective of the WEAR-AF study is to evaluate the diagnostic accuracy of wearable ECG devices in detecting AF episodes compared to standard clinical practices such as Holter monitoring and traditional ECGs Secondary objectives include assessing the impact of continuous AF monitoring on clinical outcomes including stroke prevention symptom management and patient quality of life The study will also examine patient adherence to the use of wearable technology and its influence on healthcare utilization and costs
Study Design
WEAR-AF is a prospective observational study that will enroll participants across multiple centers Eligible participants include individuals diagnosed with AF or those at high risk for developing AF Participants will be provided with wearable devices equipped with ECG capabilities and will be monitored over a specified period The study will compare the AF detection rates of these wearable devices against standard diagnostic tools evaluate the consistency of AF management with the wearable devices data and document any changes in clinical outcomes over time
Endpoints
Primary Endpoint
Diagnostic accuracy of wearable ECG devices in detecting AF compared to standard methods
Secondary Endpoints
Impact of wearable ECG monitoring on stroke incidence and other cardiovascular events
Changes in AF-related symptoms and quality of life as measured by validated questionnaires
Patient adherence to the use of wearable technology for continuous AF monitoring
Healthcare utilization and cost-effectiveness analysis
Significance
The WEAR-AF study aims to generate robust evidence on the role of wearable technology in managing AF By providing insights into the accuracy utility and patient adherence to these devices the study will contribute to the development of guidelines for the integration of wearable technology into clinical practice The ultimate goal is to improve patient outcomes by enabling more timely and precise management of AF
Conclusion
The WEAR-AF study will explore the potential of wearable technology to transform the management of atrial fibrillation Through this research we aim to provide valuable data on the effectiveness of wearable ECG devices in real-world settings offering a foundation for future innovations in digital health and personalized medicine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None