The PRIME-LOOP study is a prospective cohort investigating the burden of atrial fibrillation (AF) and subclinical AF in patients with moderate-severe or severe primary mitral regurgitation (MR). The study will use long-term cardiac monitoring with an implantable loop recorder (ILR) for up to three years to identify the burden of AF. Further, the study aims to examine the associated risk of adverse events among patients with detected AF as compared with patients without AF. Only patients with no or mild symptoms related to MR and without a class I indication for surgical intervention will be included. The study aims to include 100 patients.
Patients will be screened from the PRIME cohort - a prospective cohort of patients with primary MR in East Denmark.
Asymptomatic/mildly symptomatic*, significant primary MR**
LVEF ≥60%
Native mitral valve
Age ≥18 years old
Prior diagnosis of AF
Prescence of cardiac pacemaker, ICD, cardiac resynchronization device, loop recorder, or a clinical indication for loop recorder
LVESD ≥ 40 mm
Planned for mitral valve surgery
Patients with moderat-severe or severe primary mitral regurgitation with no or mild symptoms without a class I indication for surgical intervention
Cohort
Prospective
Not listed
Atrial fibrillation detection
Episode of ≥6 minutes of consecutive AF at any time during the 3-year monitoring time
Atrial fibrillation detection
Episode of ≥2 minutes of consecutive AF
Supraventricular tachycardia
Rate \>150 bpm lasting ≥16 beats
Sinus arrest/asystole
Pauses \> 3 seconds
Atrioventricular block
Second-degree or complete block with ≥4 beats at a rate \<30 bpm
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