NCT07377799Not yet recruiting
Study for the Identification of Subclinical Atrial Fibrillation In Patients With Significant Primary Mitral Regurgitation
PRospective Cohort Study for the Identification of Subclinical Atrial Fibrillation In Patients With Significant Primary Mitral Valve Regurgitation
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 22 Jan 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Atrial fibrillation
- NCT number
- NCT07377799
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Feb 2026 to the primary completion date, 1 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior diagnosis of AF
- Planned for mitral valve surgery
Other illness
- Prescence of cardiac pacemaker, ICD, cardiac resynchronization device, loop recorder, or a clinical indication for loop recorder
Other
- LVESD ≥ 40 mm
- Life expectancy \< 1 year
- Pregnancy or lactating
Who the study is looking for
- Asymptomatic/mildly symptomatic\*, significant primary MR\*\*
- LVEF ≥60%
- Native mitral valve
- Age ≥18 years old
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.