Left Atrial Isolation by Catheter Ablation in Persistent Atrial Fibrillation With Severe Atrial Fibrosis

Shanghai Chest Hospital50 enrolled

Overview

This is a single-arm clinical trial evaluating the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

This is a single-arm clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are enrolled as subjects to conduct left atrial isolation by catheter ablation. Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Persistent Atrial Fibrillation

Interventions

Left atrial isolation by catheter ablationPROCEDURE

Procedure: Right pulmonary vein circumferential isolation + anterior left atrial line (superior mitral annulus to right superior pulmonary vein via the anterior wall) + para-septal line (para-septal mitral annulus to the right inferior pulmonary vein, including right atrial components-especially in and around the proximal coronary sinus) + posterior left atrial line (superior mitral annulus to right superior pulmonary vein via the posterior wall).

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 and left atrial anterioposterior diameter \> 50mm 3. Nonresponse or intolerance to ≥1 antiarrhythmic drug 4. CHA2DS2-VASc ≥ 3 and HAS-BLED \< 3 Exclusion Criteria: 1. With uncontrolled congestive heart failure; 2. Having significant valvular disease; 3. Having moderate-to-severe pulmonary hypertension; 4. With myocardial infarction or stroke within 6 months of screening; 5. With Significant congenital heart disease; 6. Ejection fraction was \<40% measured by echocardiography; 7. Allergic to contrast media; 8. Contraindication to anticoagulation medications; 9. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD); 10. Left atrial thrombus; 11. Having any contraindication to right or left sided heart catheterization

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