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

NCT06552845 | Recruiting

• 1 other identifier: 2023-2223
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to:

1. 1.Assess the consistency of LGE-MRI bi-atrial fibrosis and electroanatomical mapping of bi-atrial low voltage region
2. 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. 3.To explore the correlation between preoperative and postoperative bi-atrial fibrosis and long-term recurrence in patients with atrial fibrillation.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Observational Group

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 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

Interventions

LGE-MRI Scan DIAGNOSTIC_TEST

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

Observational Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 14, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

CN (1)