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

NCT ID: NCT05887453

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-22
• Study Completion Date: 2023-12-31

Brief Summary

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1: Persistent AF

Magnetocardiography

Intervention Type: DEVICE

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

Magnetocardiography

Intervention Type: DEVICE

Magnetocardiography is a device used to exam the dynamic magnetic map of the heart for the diagnosis of some heart diseases

Healthy controls

Magnetocardiography

Intervention Type: DEVICE

Magnetocardiography is a device used to exam the dynamic magnetic map of the heart for the diagnosis of some heart diseases

Interventions

Magnetocardiography

Magnetocardiography is a device used to exam the dynamic magnetic map of the heart for the diagnosis of some heart diseases

Intervention Type: DEVICE

Eligibility Criteria

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;

• 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;

• 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;
• 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)

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian'an Wang

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian'an Wang

Role: CONTACT

wangjianan111@zju.edu.cn

+86-13805786328

Facility Contacts

Jian'an Wang

Role: primary

Other Identifiers

JWang

Identifier Type: -

Identifier Source: org_study_id