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Consistency of LGE-MRI Fibrosis and EAM Low-voltage Area

Exploratory Study of Consistency of Bi-Atrial Fibrosis Detected by Late Gadolinium Enhancement Magnetic Resonance Imaging and Low Voltage Area of Electroanatomic Mapping

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06552845
Enrollment
50
Registered
2024-08-14
Start date
2024-04-01
Completion date
2025-12-31
Last updated
2024-08-14

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 study aims to: 1. Assess the consistency of LGE-MRI bi-atrial fibrosis and electroanatomical mapping of bi-atrial low voltage region 2. To evaluate the electroanatomical characteristics of different types of fibrosis (dense fibrosis, patchy fibrosis, etc.) in different locations of the left and right atrium; 3. To explore the correlation between preoperative and postoperative bi-atrial fibrosis and long-term recurrence in patients with atrial fibrillation.

Interventions

DIAGNOSTIC_TESTLGE-MRI Scan

Participants will receive LGE-MRI scan before catheter ablation and 3 months after catheter ablation

Sponsors

China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

1. Adult patients (≥18 years old) who are willing to participate in this study and can sign informed consent; 2. Atrial fibrillation was diagnosed and catheter ablation was proposed

Exclusion criteria

1. Left atrial thrombus or left atrial appendage thrombus; 2. Severe chronic obstructive pulmonary disease (FEV1/ FVC\<70%, FEV1\<50% predicted value); 3. Absolute contraindications of anticoagulation therapy; 4. Currently pregnant; 5. Contraindications for LGE-MRI (claustrophobia, pacemaker implantation, eGFR\<30ml/min for renal insufficiency, severe obesity, pregnancy, gadolinium chelating agent allergy, etc.); 6. refuse to participate in the study; 7. other physical or mental incapacity to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
Consistency of LGE-MRI fibrosis and EAM low-voltage areaBaseline (at recruit time point)Use Registration to match the corresponding spatial points of LGE-MRI and EAM。Each spatial points will contain two types of status(Fibrosis: Yes/No, Low-voltage area: Yes/No). Chi-square test will be used to assess the consistency of fibrosis and low-voltage area.

Countries

China

Outcome results

None listed

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