About this trial
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.
Eligibility criteria
Qualifiers
Asymptomatic/mildly symptomatic*, significant primary MR**
LVEF ≥60%
Native mitral valve
Age ≥18 years old
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed