Not Yet RecruitingNot Applicable

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

Denmark100 participantsStarted 2026-02-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Atrial fibrillation detection

Timeframe: 3 years

Trial details

NCT IDNCT07377799

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-02-01

Contact for this trial

Lauge Klement Moltke Østergaard, MD PhD

0045 35454295 lauge.klement.moltke.oestergaard.02@regionh.dk

View on ClinicalTrials.gov More Mitral Regurgitation trials