Catheter Ablation and Surgical Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis

Shanghai Chest Hospital300 enrolled

Overview

This is an open label, randomized parallel control clinical trial evaluating the efficacy and safety of catheter ablation and surgical ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

This is an open label, randomized parallel control clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are 1:1:1 randomized into the group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion) and group C (surgical ablation). Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of catheter ablation and surgical ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Persistent Atrial Fibrillation

Interventions

Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablationPROCEDURE

Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and driver ablation.

Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusionPROCEDURE

Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with vein of Marshall ethanol infusion.

Surgical ablationPROCEDURE

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 with severe atrial fibrosis; 3. Nonresponse or intolerance to ≥1 antiarrhythmic drug. Exclusion Criteria: 1. With uncontrolled congestive heart failure; 2. Having significant valvular disease; 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; 10. Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation; 12\. Presence of an implanted cardioverter-defibrillator; 13. Previous history of cardiac surgery; 14. Poor general health; 15. Life expectancy less than 6 months.

Outcomes

Primary Outcomes

Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate

AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration