Clinical trial NCT04489004: The Chinese Registration Study of Driver Ablation of Persistent Atrial Fibrillation.
Official title: Credit-AF: A Randomized Control Study of Driver Ablation Combined With Circumferential Pulmonary Vein Isolation Versus Stepwise Ablation as a Treatment in Patients With Persistent Atrial Fibrillation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation, Persistent
Keywords: Persistent Atrial Fibrillation
Driver ablation
Stepwise ablation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 1298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative atrial fibrillation (AF) recurrence rate
timeFrame: up to 24 months after enrollment
measure: Procedural AF termination rate
timeFrame: Before the end of procedure.
Secondary outcomes:
measure: Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate
timeFrame: up to 24 months after enrollment
measure: Incidence of complications
timeFrame: up to 2 weeks after enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References: