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

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT06552845
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Consistency of LGE-MRI fibrosis and EAM low-voltage area	Baseline (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.

Trial Locations

Locations (1)

Fuwai Hospital, CAMS&PUMC; 🇨🇳 Beijing, Beijing, China