Early Aggressive Invasive Intervention for Atrial Fibrillation

Summary

Participation Requirements

Description

The EARLY-AF study is centered on an evaluation of the impact of the early invasive management of Atrial Fibrillation. All patients will undergo a loop recorder implantation (REVEAL LINQ, Medtronic), also called an insertable cardiac monitor (ICM), at the time of study enrolment using standard clini...

The EARLY-AF study is centered on an evaluation of the impact of the early invasive management of Atrial Fibrillation. All patients will undergo a loop recorder implantation (REVEAL LINQ, Medtronic), also called an insertable cardiac monitor (ICM), at the time of study enrolment using standard clinical implant procedures. The primary goal of the study is to evaluate the clinical effectiveness of an early invasive approach. Specifically, the investigators are aiming to evaluate if PVI performed with the Arctic Front cryoballoon is superior to AAD as first-line therapy in preventing atrial arrhythmia recurrences (arrhythmia related symptoms, hospitalisations, and health care utilization). The secondary goal of the program is to evaluate the health related quality of life (HRQOL) impact associated with early invasive intervention, in comparison to primary AAD therapy. This analysis will be centered on an evaluation of generic and disease-specific HRQOL instruments in order to determine the impact of an early invasive approach. A secondary benefit is the derivation of a Quality Adjusted Life Years (QALYs) score, which can be used as a summary measure of health outcome and to inform subsequent healthcare resource allocation decisions.

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