Atrial Fibrillation, Persistent
Conditions
Keywords
Persistent Atrial Fibrillation, Driver ablation, Stepwise ablation
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.
Interventions
PROCEDUREDriver ablation+CPVI
Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation).
PROCEDUREStepwise ablation
Patients receive stepwise ablation.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative atrial fibrillation (AF) recurrence rate | up to 24 months after enrollment | AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration. |
| Procedural AF termination rate | Before the end of procedure. | AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate | up to 24 months after enrollment | Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration. |
| Incidence of complications | up to 2 weeks after enrollment | Complications include: death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischemic attack (TIA), diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis, and major vascular access complication or bleeding. |
Countries
China
Outcome results
None listed