NCT06327425

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

March 14, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

August 21, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

March 11, 2024

Last Update Submit

August 19, 2024

Conditions

TachyarrhythmiaAtrial FlutterParoxysmal Supraventricular TachycardiaAtrial TachycardiaAtrial FibrillationPremature Ventricular Contraction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patients with atrial tachycardia

EXPERIMENTAL

Patients with atrial tachycardia will receive dynamic ECG, MCG and cardiac electrophysiologic examinations.

Device: Magnetocardiography

Patients with atrial flutter

EXPERIMENTAL

Patients with atrial flutter will receive dynamic ECG, MCG and cardiac electrophysiologic examinations.

Device: Magnetocardiography

Interventions

MagnetocardiographyDEVICE

Magnetocardiography

Patients with atrial flutterPatients with atrial tachycardia

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China, Shandong Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

TachycardiaAtrial FlutterTachycardia, VentricularAtrial FibrillationVentricular Premature Complexes

Interventions

Magnetocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsCardiac Complexes, Premature

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative Techniques

Study Officials

  • Yuguo Chen, Professor

    Qliu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaojiao Pang, Doctor

CONTACT

0086-0531-82165398jiaojiaopang@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2024

First Posted

March 25, 2024

Study Start

March 14, 2024

Primary Completion

December 1, 2024

Study Completion

February 1, 2025

Last Updated

August 21, 2024

Record last verified: 2024-02

Locations

CN(1)