The Chinese Registration Study of Driver Ablation of Persistent Atrial Fibrillation.

Shanghai Jiao Tong University

Status: Completed

Conditions: Atrial Fibrillation, Persistent

Treatments: Procedure: Stepwise ablation; Procedure: Driver ablation+CPVI

Study type: Interventional

Funder types: Other

Identifiers

NCT04489004

Credit-AF

Details and patient eligibility

About

This is an open label, multi-center, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.

Full description

This is an open label, multi-center, randomized parallel control clinical trial. Patients with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation). Postoperative atrial fibrillation recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.

Enrollment: 1,298 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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;
12. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,298 participants in 2 patient groups

Driver ablation+CPVI

Experimental group

Description:

Driver ablation plus CPVI (circumferential pulmonary vein isolation)

Treatment:

Procedure: Driver ablation+CPVI

Stepwise ablation

Active Comparator group

Description:

Stepwise ablation

Treatment:

Procedure: Stepwise ablation