The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation and Recurrent Events Evaluation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFirst Hospital of China Medical University
About this trial
Atrial fibrillation (AF) is the most common cardiac arrhythmia in the clinic and can lead to valve regurgitation and a poor prognosis. At present, atrial fibrillation ablation is one of the most effective means for the recurrence of atrial fibrillation in clinical practice, but the recurrence rate is high. Therefore, it is of great significance to find the predictors of relapse after atrial fibrillation ablation for clinical precision treatment. three-dimensional transesophageal ultrasound (3D-TEE) can comprehensively evaluate the valve regurgitation, flap ring changes, atrial or auricular thrombosis in patients with atrial fibrillation. It is also a necessary examination before atrial fibrillation ablation.
Therefore, this study intends to combine 3D-TEE and three-dimensional transthoracic echocardiographic (3D-TTE) examination to evaluate the cardiac structure and function of patients. To comprehensively evaluate atrial fibrillation valve regurgitation and explore the predictors of recurrence after atrial fibrillation ablation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old;
Patients who came to the hospital with atrial fibrillation and intended to undergo ablation.
Disqualifiers
- History of left atrial or left atrial appendix thrombus, new cerebral infarction and myocardial infarction (< 6 months);
Congenital heart disease, valvular heart disease, dilated heart disease, hypertrophic cardiomyopathy, pacemaker implantation, artificial valve replacement;
hyperthyroidism, severe liver and kidney insufficiency;
Proposed cardiac pacemaker implantation;
Trial population
Atrial fibrillation population in China
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 1 trial groupGroup A: AF group
Trial outcomes
Primary outcomes
1
Recurrence of atrial fibrillation
Using 12-lead electrocardiogram and 24h-holter electrocardiogram to exam patients. The recurrence of atrial fibrillation is defined as atrial tachycardia, atrial flutter or atrial fibrillation lasting for 30 seconds or more.
Time frame
3 months after atrial fibrillation ablationOther outcomes
1
mitral or tricuspid regurgitation improvement
1. Utilize three-dimensional ultrasound technology to measure multiple parameters of the mitral valve annulus and tricuspid valve annulus, including annulus area (cm2), circumference (cm), non-planar angle (°), etc. Compare the differences of these parameters with the baseline state at 3 months. 2. Use Doppler technology to assess the improvement or deterioration of mitral and tricuspid regurgitation, including regurgitation diameter (mm), regurgitation area (cm2).
Time frame
3 months after atrial fibrillation ablationSponsors and contacts
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Source ClinicalTrials.gov