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

NCT07377799 · tracked via the Priya Life Science Denmark tracker

Sponsor

Rigshospitalet, Denmark

Phase

Observational

Started

2026-02-01

Last updated

2026-02-02

Condition(s) studied

Mitral RegurgitationAtrial Fibrillation (AF)

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Atrial fibrillation detection — 3 years
Episode of ≥6 minutes of consecutive AF at any time during the 3-year monitoring time

Trial sites (1)

Facility	City	Region	Status
Rigshospitalet	Copenhagen	Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07377799 on ClinicalTrials.gov ↗ ← All trials in Denmark