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Clinical Trials/NCT06552845
NCT06552845RecruitingNot Applicable

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

China National Center for Cardiovascular Diseases1 site in 1 country50 target enrollmentStarted: April 1, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Consistency of LGE-MRI fibrosis and EAM low-voltage area
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

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

Outcomes

Primary Outcomes

Consistency of LGE-MRI fibrosis and EAM low-voltage area

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
China National Center for Cardiovascular Diseases
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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