Study for the Identification of Subclinical Atrial Fibrillation In Patients With Significant Primary Mitral Regurgitation

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.

NCT Number	NCT07377799
Lead Sponsor	Rigshospitalet, Denmark
Conditions	Mitral Regurgitation, Atrial Fibrillation (AF)
Enrollment	100 participants
Start Date	2026-02-01
Primary Completion	2028-02-01 (estimated)
Study Completion	2031-02-01 (estimated)
Updated on ClinicalTrials.gov	2026-02-02