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

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Conditions studied: Mitral Regurgitation, Atrial Fibrillation (AF)

In brief

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.

Key facts

Study ID

NCT07377799

Run by

Rigshospitalet, Denmark

People needed

100

Starts

2026-02-01

Expected to finish

2031-02-01

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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
• Life expectancy < 1 year
• Pregnancy or lactating

Where it is running

• Rigshospitalet — Copenhagen, Denmark

Full record on ClinicalTrials.gov

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