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

NCT07377799 | Not Yet Recruiting

• 2 other identifiers: 16-0302-9NNF23OC0081668
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Regurgitation; Atrial Fibrillation (AF)

Keywords

degenerative mitral regurgitation; asymptomatic; atrial fibrillation; subclinical atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation detection

  Episode of ≥6 minutes of consecutive AF at any time during the 3-year monitoring time

  3 years

Secondary Outcomes (22)

• Atrial fibrillation detection

  3 years

• Supraventricular tachycardia

  3 years

• Sinus arrest/asystole

  3 years

• Atrioventricular block

  3 years

• Sustained ventricular tachycardia

  3 years

Study Arms (1)

Patients with ILR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderat-severe or severe primary mitral regurgitation with no or mild symptoms without a class I indication for surgical intervention

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lauge Klement Moltke Østergaard, MD PhD

CONTACT

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

Jeppe Petersen, MD

CONTACT

jeppe.kjaergaard.petersen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRospective cohort study for the Identification of Subclinical atrial fibrillation In patients with significant primary Mitral valve regurgitation

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 30, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2031
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)