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

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Device: Magnetocardiography

• Registration Number: NCT05887453
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-22
• Study First Submitted: 2023-03-26
• Study First Submitted QC: 2023-05-24
• Last Update Submitted: 2023-05-24
• Study First Posted: 2023-06-02
• Last Update Posted: 2023-06-02
• Primary Completion: 2023-08
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2 : Paroxysmal AF	Magnetocardiography	-
Healthy controls	Magnetocardiography	-
Group 1: Persistent AF	Magnetocardiography	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China