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

Shanghai Chest Hospital1,298 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,298

Conditions

Atrial Fibrillation, Persistent

Interventions

Driver ablation+CPVIPROCEDURE

Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation).

Stepwise ablationPROCEDURE

Patients receive stepwise ablation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, China

Outcomes

Primary Outcomes

Postoperative atrial fibrillation (AF) recurrence rate

AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.

Time frame: up to 24 months after enrollment

Procedural AF termination rate

AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT).

Time frame: Before the end of procedure.

Secondary Outcomes

Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate

Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration.

Time frame: up to 24 months after enrollment

Incidence of complications

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.

Time frame: up to 2 weeks after enrollment

Data from ClinicalTrials.gov

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