Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05887453
Enrollment
450
Registered
2023-06-02
Start date
2023-03-22
Completion date
2023-12-31
Last updated
2023-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

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

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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;

Design outcomes

Primary

MeasureTime frameDescription
sensitivity and specificity24 hoursThe sensitivity and specificity of magnetocardiography in the diagnosis of persistent AF
Independent predictors of recurrence of paroxysmal atrial fibrillation3 monthsA statistical model is used to obtain the magnetocardiographic parameters that could predict the recurrence of paroxysmal atrial fibrillation.

Countries

China

Contacts

Primary ContactJian'an Wang
wangjianan111@zju.edu.cn+86-13805786328

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026