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

Key facts

Where
Copenhagen, DenmarkSee the site

Where in Denmark

  • RigshospitaletCopenhagen, DenmarkNo longer taking part

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Trial details

Who runs it
Copenhagen University Hospital, Rigshospitalet
Trial code
NCT07377799
Record updated
2 February 2026
Original description
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.Read full original descriptionShow less

PRospective Cohort Study for the Identification of Subclinical Atrial Fibrillation In Patients With Significant Primary Mitral Valve 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.

Inclusion: Asymptomatic/mildly symptomatic*, significant primary MR**; LVEF ≥60%; Native mitral valve; Age ≥18 years old.

Exclusion: Prior diagnosis of AF; Planned for mitral valve surgery; Prescence of cardiac pacemaker, ICD, cardiac resynchronization device, loop recorder, or a clinical indication for loop recorder; LVESD ≥ 40 mm; Life expectancy < 1 year; Pregnancy or lactating.

ClinicalTrials.gov NCT07377799