Termination of Persistent Atrial Fibrillation by Catheter Ablation

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Catheter ablation

• Registration Number: NCT04958928
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

This is a prospective, multicenter, cohort study aims to demonstrate the role of termination of AF in ablation for persistent atrial fibrillation, and evaluate the clinical outcomes in patients with or without AF termination.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-09
• Last Update Submitted: 2021-07-09
• Study First Posted: 2021-07-12
• Last Update Posted: 2021-07-12
• Study Start: 2021-08-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Aged 18 to 80 years old; 2. Persistent AF; 3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.

Exclusion Criteria

1. With uncontrolled congestive heart failure;

2. Having significant valvular disease and/or prosthetic heart valve(s);

3. With myocardial infarction or stroke within 6 months of screening;

4. With Significant congenital heart disease;

5. Ejection fraction was <40% measured by echocardiography;

6. Allergic to contrast media;

7. Contraindication to anticoagulation medications;

8. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);

9. Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography;

10. Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;

11. Presence of an implanted cardioverter-defibrillator; 13. Any cardiac surgery within the past 2 months; 14. Poor general health; 15.Life expectancy less than 6 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Persistent AF Group	Catheter ablation	-

Primary Outcome Measures

Name	Time	Method
AF recurrence rate	12 months	AF recurrence is defined as presence of documented AF episodes of 30 recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.