Presence of at least 1 AF episode
Time frame · First 52 weeks of the study
Presence of at least 1 AF episode (present or absent) in a 2-week monitoring time by Zio XT Patch at 52 weeks.
Change in number of AF episodes (≥30 seconds)
Time frame · First 52 weeks of the study
Change in Zio XT Patch derived variables from baseline to 52 weeks including number of AF episodes (≥30 seconds) in a 2-week monitoring time.
Change in number of AF espisodes longer than 6 minutes
Time frame · First 52 weeks of the study
Change in Zio XT Patch derived variables from baseline to 52 weeks including number of AF episodes longer than 6 minutes in a 2-week monitoring time.
Change in the longest AF duration
Time frame · First 52 weeks of the study
Change in Zio XT Patch derived variables from baseline to 52 weeks including the longest AF duration in a 2-week monitoring time.
Change in the second longest AF duration
Time frame · First 52 weeks of the study
Change in Zio XT Patch derived variables from baseline to 52 weeks including the second longest AF duration in a 2-week monitoring time.
Change in the AF type
Time frame · First 52 weeks of the study
Change in the AF type (e.g. regression from or progression to persistent form of AF)
Change in AF Symptom burden
Time frame · First 52 weeks of the study
Change in AF Symptom burden and severity assessed by the Toronto AF Severity Score (AFSS)
Relapse of AF after ablation
Time frame · Throughout the study, 130 weeks
Number of relapses of AF after ablation in each group
\*Since more ablation is expected in the second phase of study, this end point will be more relevant in the phase 2 of study.
Change in cardiac structure
Time frame · First 52 weeks of the study
Change in cardiac structure assessed by transthoracic echocardiography including LA and LV size, morphology, and function
Change in weight
Time frame · First 52 weeks of the study
Percent and absolute changes in body weight and BMI