An Exploratory Clinical Study to Evaluate the Specificity of Magnetocardiogram in Atrial Fibrillation and the Prediction of Recurrence

Study Overview
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Brief Summary
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This is a prospective, observational clinical study with150 patients of persistent AF (trial group 1), 150 patients of paroxysmal AF (trial group 2), and 150 healthy subjects (control group). The trial is divided into two parts. The aim of first part is to evaluate the sensitivity and specificity of magnetocardiography on diagnosing persistent AF, and the second part is to evaluate the independent predictors of magnetocardiography on predicting recurrence of paroxysmal AF. The patients who had been diagnosed with AF in OPD or IPD will be included. After signing the informed consent letter, medical history of all subjects will be collected, including magnetic cardiogram, 12-lead electrocardiogram, holter electrocardiogram, cardiac ultrasound and blood tests. Patients with paroxysmal AF will be followed up for 3 months, and the recurrence of AF is the observation end point.

Official Title
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An Exploratory Clinical Study to Evaluate the Specificity of Magnetocardiogram in Atrial Fibrillation and the Prediction of Recurrence

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Magnetocardiography


Participation Criteria
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Eligibility Criteria
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Group: Group 1 (Persistent AF) Inclusion criteria： Persistent AF is recorded by ECG before the examination of the magnetocardiogram; Detailed clinical records, including medical history, cardiovascular risk factors, blood tests, and antiarrhythmic drug therapy; It is recommended that antiarrhythmic drugs be discontinued at least 5 days before the examination and continue if atrial fibrillation occurs or the symptoms of atrial fibrillation are obvious; Exclusion criteria: Severe valvular heart disease, structural heart disease, heart function classification ≥ New York Heart Association functional class II, history of ischemic heart disease, left ventricular ejection fraction < 50%, hyperthyroidism, primary pulmonary hypertension, and respiratory disease; Patients after radiofrequency ablation; The implanted devices in the body effect the magnetic signal during the detection process, such as prosthetic limbs, heart stents or valves contain metal material. Unable to maintain the supine position during the examination. Group: Group 2 (Paroxysmal AF) Inclusion criteria: Persistent AF is recorded by ECG before the examination of the magnetocardiogram; Detailed clinical records, including medical history, cardiovascular risk factors, blood tests, and antiarrhythmic drug therapy; It is recommended that antiarrhythmic drugs be discontinued at least 5 days before the examination and continue if atrial fibrillation occurs or the symptoms of atrial fibrillation are obvious; Exclusion criteria: Severe valvular heart disease, structural heart disease, heart function classification ≥ New York Heart Association functional class II, history of ischemic heart disease, left ventricular ejection fraction < 50%, hyperthyroidism, primary pulmonary hypertension, and respiratory disease; Patients after radiofrequency ablation; The implanted devices in the body effect the magnetic signal during the detection process, such as prosthetic limbs, heart stents or valves contain metal material. Unable to maintain the supine position during the examination. Group: Control group Inclusion criteria: No history of AFor other arrhythmias; Detailed clinical records, including medical history and cardiovascular risk factors; Exclusion criteria: severe valvular heart disease, structural heart disease,heart function classification ≥ New York Heart Association functional class II, history of ischemic heart disease, left ventricular ejection fraction < 50%, hyperthyroidism, primary pulmonary hypertension, and respiratory disease; The implanted devices in the body effect the magnetic signal during the detection process, such as prosthetic limbs, heart stents or valves contain metal material. Unable to maintain the supine position during the examination.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Persistent AF<br> | Device: Magnetocardiography<br>* Magnetocardiography is a device used to exam the dynamic magnetic map of the heart for the diagnosis of some heart diseases<br>|
| Group 2 : Paroxysmal AF<br> | Device: Magnetocardiography<br>* Magnetocardiography is a device used to exam the dynamic magnetic map of the heart for the diagnosis of some heart diseases<br>|
| Healthy controls<br> | Device: Magnetocardiography<br>* Magnetocardiography is a device used to exam the dynamic magnetic map of the heart for the diagnosis of some heart diseases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity and specificity | The sensitivity and specificity of magnetocardiography in the diagnosis of persistent AF | 24 hours | 
| Independent predictors of recurrence of paroxysmal atrial fibrillation | A statistical model is used to obtain the magnetocardiographic parameters that could predict the recurrence of paroxysmal atrial fibrillation. | 3 months |