Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 2 trial groups
Group A: Catheter ablation cohort
Group B: Drug treatment cohort

Trial outcomes

Primary outcomes

1

Improvement in MR

Defined as a decrease of ≥1 level in the severity stage at 1 year compared to baseline

Time frame
3-month, 6-month, 12-month at follow-up

Secondary outcomes

1

Changes of MR in echocardiography examination

Effective regurgitant area, regurgitant volume, and regurgitant fraction of the mitral valve from baseline

Time frame
3-month, 6-month, 12-month at follow-up
2

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'

Time frame
3-month, 6-month, 12-month at follow-up
3

Changes of left atrial function in echocardiography examination

Left atrial anteroposterior diameter and left atrial end-diastolic volume

Time frame
3-month, 6-month, 12-month at follow-up
4

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)

Time frame
12-month at follow-up

Other outcomes

Sponsors and contacts

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