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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.
Atrial fibrillation results in the loss of the atria's normal contracting ability, leading to blood stasis within the left atrium and its subsequent enlargement. This condition can progress to cause dilation of the mitral annulus and mitral regurgitation-a phenomenon referred to as functional mitral regurgitation (FMR). Atrial functional mitral regurgitation (AFMR), triggered by the enlargement of the left atrium and remodeling of the mitral annulus, has increasingly become a focal point of research in recent times. Past studies have indicated that in patients who revert to and maintain sinus rhythm following catheter ablation for atrial fibrillation, there is a notable reduction in the size of the left atrium, the diameter of the mitral annulus, and the severity of mitral regurgitation. This suggests that patients with AFMR may derive significant benefits from the restoration of sinus rhythm. This investigation constitutes a prospective, multicenter cohort study. Eligible patients diagnosed with atrial fibrillation accompanied by atrial functional mitral regurgitation, who meet the inclusion criteria and do not fulfill the exclusion criteria, are being recruited. Depending on clinical judgment or patient preference, participants are assigned to receive either catheter ablation for atrial fibrillation or standard medical therapy, with the aim of assessing the impact of these different treatments on alleviating the degree of mitral regurgitation. The study aims to enroll 500 patients, with follow-up assessments scheduled at 3-month, 6-month, and 12-month intervals following enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter ablation cohort | Patients who receive pulsed field ablation procedure | ||
| Drug treatment cohort | Patients who receive regular drug therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement in MR | Defined as a decrease of ≥1 level in the severity stage at 1 year compared to baseline | 3-month, 6-month, 12-month at follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of MR in echocardiography examination | Effective regurgitant area, regurgitant volume, and regurgitant fraction of the mitral valve from baseline | 3-month, 6-month, 12-month at follow-up |
| Changes of left ventricular function in echocardiography examination |
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Inclusion Criteria:
Exclusion Criteria:
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Atrial fibrillation combined with atrial functional mitral regurgitation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianbao Liu, Dorctor | Contact | 086-571-87784705 | liuxb@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianan Wang, Dorctor | Second Affiliated Hospital of Zhejiang University, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Zhejiang University, School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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' |
| 3-month, 6-month, 12-month at follow-up |
| Changes of left atrial function in echocardiography examination | Left atrial anteroposterior diameter and left atrial end-diastolic volume | 3-month, 6-month, 12-month at follow-up |
| 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) | 12-month at follow-up |
| Burden of atrial arrhythmia | Incidence and duration of atrial arrhythmias (atrial premature contractions, atrial tachycardia, atrial flutter, and atrial fibrillation) | 12-month at follow-up |
| Acute PVI success | Immediate success rate of pulmonary vein isolation | Immediately after cathete ablation procedure |
| Procedure time | Total procedure time, atrial fibrillation ablation time, radiofrequency energy time, and total fluoroscopy time | Immediately after cathete ablation procedure |
| Incidence rate of major adverse events | death, myocardial infarction, pulmonary vein stenosis, diaphragmatic nerve palsy, systemic embolism, TIA/ischemic stroke, pericarditis, pericardial effusion/cardiac tamponade, atrioesophageal fistula, and severe vascular access complications | 3-month, 6-month, 12-month at follow-up |
| Incidence of heart failure-related events | Including readmissions, stroke, and all-cause mortality | 3-month, 6-month, 12-month at follow-up |
| Changes in QoL | KCCQ score and NYHA classification | 3-month, 6-month, 12-month at follow-up |
| D013568 |
| Pathological Conditions, Signs and Symptoms |