MCG for Localization of Tachyarrhythmia's Origin

Atrial Fibrillation Clinical Trial

Official title:

Magnetocardiography for Precise Identification of the Site of Origin of Tachyarrhythmia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06327425
• Other study ID #: MCG-Tachyarrhythmia
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Qilu Hospital of Shandong University
• Contact: Jiaojiao Pang, Doctor
• Phone: 0086-0531-82165398
• Email: jiaojiaopang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an exploratory research aiming to accurately identify the site of origin of tachyarrhythmia using Magnetocardiography (MCG), which will have guiding significance for early diagnosis, the formulation of treatment plans and preoperative positioning for radiofrequency ablation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Age 18-79 years old;

• Those whose conditions are comparatively stable and who have been diagnosed by an attending physician (or physicians with higher qualifications) with paroxysmal supraventricular tachycardia, atrial tachycardia, atrial flutter, atrial fibrillation, or premature ventricular contractions, and who are capable of performing MCG and cardiac electrophysiologic examinations after evaluation.

• Signed informed consent.

Exclusion Criteria:

• Those with known structural heart disease such as cardiomyopathy and valvular disease;

• Those with history of other cardiovascular diseases such as pulmonary embolism and aortic dissection;

• Those with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.) combined with cardiac complications;

• Those with obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply;

• Those with Obese (BMI>30kg/cm2) or underweight (BMI<18kg/cm2);

• Those with malignant tumors;

• Professional athletes, pregnant or breastfeeding women, alcoholics;

• Those with acute diseases or critical illnesses in other systems, such as acute or severe respiratory diseases, abnormal liver function or renal function, etc.;

• Those with infectious diseases or communicable diseases;

• Those who are unable or fail to perform magnetocardiography due to claustrophobia, physical impairment, etc.;

• Unable to or fail to cooperate with the corresponding research requirements.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Atrial Tachycardia
• Paroxysmal Supraventricular Tachycardia
• Premature Ventricular Contraction
• Tachyarrhythmia
• Tachycardia
• Tachycardia, Supraventricular
• Tachycardia, Ventricular
• Ventricular Premature Complexes

Intervention

Device:
• Magnetocardiography
Magnetocardiography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of MCG to detect the site of origin of Tachyarrhythmia using cardiac electrophysiology as a reference standard.	Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.	12 month course of the disease