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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Magnetocardiography

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Jian'an Wang; Phone Number: +86-13805786328; Email: wangjianan111@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Jian'an Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with atrial fibrillation and healthy people without arrhythmia

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls	Device: Magnetocardiography; Magnetocardiography is a device used to exam the dynamic magnetic map of the heart for the diagnosis of some heart diseases
Group 1: Persistent AF	Device: Magnetocardiography; Magnetocardiography is a device used to exam the dynamic magnetic map of the heart for the diagnosis of some heart diseases
Group 2 : Paroxysmal AF	Device: Magnetocardiography; Magnetocardiography is a device used to exam the dynamic magnetic map of the heart for the diagnosis of some heart diseases

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Jian'an Wang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: JWang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No