About this trial
To evaluate the improvement of mitral regurgitation after catheter ablation of atrial fibrillation or regular drug therapy in atrial fibrillation patients combined with atrial functional mitral regurgitation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 to 80 years old;
Patients diagnosed with symptomatic paroxysmal atrial fibrillation (AF history < 5 years)
Moderate to severe MR and normal LV ejection fraction (≥50%), LVEDD<55 mm, and normal LV wall systolic function
Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol
Disqualifiers
Atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible factors
Active endocarditis or active rheumatic heart disease, or degenerative mitral regurgitation due to endocarditis or rheumatic valvular heart disease
Moderate to severe mitral stenosis
Imaging examination shows left atrium or left atrial appendage thrombosis
Trial population
Atrial fibrillation combined with atrial functional mitral regurgitation
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Improvement in MR
Defined as a decrease of ≥1 level in the severity stage at 1 year compared to baseline
Secondary outcomes
Changes of MR in echocardiography examination
Effective regurgitant area, regurgitant volume, and regurgitant fraction of the mitral valve from baseline
Changes of left ventricular function in echocardiography examination
Left ventricular ejection fraction, end-systolic/end-diastolic volume, end-systolic/end-diastolic diameter, early diastolic mitral valve flow velocity E, mitral annular velocity e'at the septum and lateral wall, and E/e'
Changes of left atrial function in echocardiography examination
Left atrial anteroposterior diameter and left atrial end-diastolic volume
Freedom from atrial arrhythmia recurrence
Defined as ECG data (including surface ECG and 24-h Holter) during the efficacy evaluation period (blanking period to the end of the 12-month follow-up) without recording AF, AFL, or AT (arrhythmia monitoring device ≥ 30 s)
Sponsors and contacts
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