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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark

About this trial

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 criteria

Qualifiers

Asymptomatic/mildly symptomatic*, significant primary MR**

LVEF ≥60%

Native mitral valve

Age ≥18 years old

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

100 Participants
are grouped into 1 trial group

Sponsors and collaborators