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

NCT ID: NCT06552845

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-12-31

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

LGE-MRI Scan

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

LGE-MRI Scan

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhe Zheng, MD, PhD

Role: primary

zhengzhe@fuwai.com

+86 88396051

Other Identifiers

2023-2223

Identifier Type: -

Identifier Source: org_study_id