Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis.

Study Overview
=================
Brief Summary
-----------------
This is an open label, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.

Detailed Description
-----------------
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 group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation) and group C (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion). Postoperative recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.

Official Title
-----------------
A Randomized Control Study of Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis: a Chinese Registry Study.

Conditions
-----------------
Persistent Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation
* Procedure: Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation
* Procedure: Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 to 80 years old; Persistent AF with severe atrial fibrosis; Nonresponse or intolerance to ≥1 antiarrhythmic drug. Exclusion Criteria: With uncontrolled congestive heart failure; Having significant valvular disease; 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 (LA) thrombus; 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.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation | Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation<br>* 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.<br>|
| Active Comparator: Group B<br>Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation | Procedure: Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation<br>* Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with posterior wall box isolation.<br>|
| Active Comparator: Group C<br>Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion | Procedure: Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion<br>* 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.<br>|

What is the study measuring?
-----------------
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 12 months after ablation | 
| Intraoperative AF termination rate | AF termination is defined as conversion to sinus rhythm or stable AFL/AT. | through ablation completion, an average of 3 hours | 

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 12 months after ablation | 
| 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 12 months after ablation | 
| Incidence of complications | death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis and major vascular access complication or bleeding | up to 12 months after ablation | 
| Changes in the diameter of the left atrium | Changes in the diameter of the left atrium | up to 12 months after ablation | 
| Changes in the left ventricular ejection fraction | Changes in the left ventricular ejection fraction | up to 12 months after ablation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
persistent atrial fibrillation, severe atrial fibrosis, driver ablation