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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: LGE-MRI Scan

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Fuwai Hospital, CAMS&PUMC
      • Contact: Zhe Zheng, MD, PhD; Phone Number: +86 88396051; Email: zhengzhe@fuwai.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult AF patients who are planned to receive catheter ablation and have no contraindications of LGE-MRI

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational Group; Inclusion Criteria; Adult patients (≥18 years old) who are willing to participate in this study and can sign informed consent;; Atrial fibrillation was diagnosed and catheter ablation was proposed Exclusion criteria a) Left atrial thrombus or left atrial appendage thrombus; b) Severe chronic obstructive pulmonary disease (FEV1/ FVC<70%, FEV1<50% predicted value); c) Absolute contraindications of anticoagulation therapy; d) Currently pregnant; e) Contraindications for LGE-MRI (claustrophobia, pacemaker implantation, eGFR<30ml/min for renal insufficiency, severe obesity, pregnancy, gadolinium chelating agent allergy, etc.); f) refuse to participate in the study; g) other physical or mental incapacity to participate in the study.

Diagnostic test: LGE-MRI Scan; Participants will receive LGE-MRI scan before catheter ablation and 3 months after catheter ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consistency of LGE-MRI fibrosis and EAM low-voltage area	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.	Baseline (at recruit time point)

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 11, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2023-2223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will be shared under the permission of primary investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No