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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Single-arm Study to Evaluate the Efficacy and Safety of Left Atrial Isolation Achieved by Catheter Ablation in Patients With Persistent Atrial Fibrillation and Severe Atrial Fibrosis: a Chinese Registry Study

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Left atrial isolation by catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 80 years old Persistent AF with severe atrial fibrosis and left atrial anterioposterior diameter > 50mm Nonresponse or intolerance to ≥1 antiarrhythmic drug CHA2DS2-VASc ≥ 3 and HAS-BLED < 3 Exclusion Criteria: With uncontrolled congestive heart failure; Having significant valvular disease; Having moderate-to-severe pulmonary hypertension; With myocardial infarction or stroke within 6 months of screening; With Significant congenital heart disease; Ejection fraction was <40% measured by echocardiography; Allergic to contrast media; Contraindication to anticoagulation medications; Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD); Left atrial thrombus; Having any contraindication to right or left sided heart catheterization

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left atrial isolation arm<br>All the enrolled subjects will receive left atrial isolation through catheter ablation. | Procedure: Left atrial isolation by catheter ablation<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 18 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative AF recurrence rate | AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration | up to 18 months after enrollment | 
| Postoperative AFL/AT rate | Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration | up to 18 months after enrollment | 
| Incidence of complications | including death, atrio-esophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, left atrial thrombus, pericarditis and major vascular access complication or bleeding | up to 18 months after enrollment | 
| Changes in the diameter of the left atrium and the left ventricular ejection fraction |  | up to 18 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent Atrial Fibrillation, Severe atrial fibrosis, Left atrial isolation, catheter ablation