CARTO-Finder Guided Ablation Versus Multiscale Entropy Guided Ablation in Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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This is a randomized control trial to compare the efficacy and safety of CARTO-Finder-guided ablation plus pulmonary vein isolation versus multiscale entropy (MSE)-guided pulmonary vein isolation in patients with persistent atrial fibrillation.

Detailed Description
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This is a randomized control trial. Patients with persistent atrial fibrillation are enrolled and randomized to CARTO-Finder-guided ablation plus PVI group or MSE-guided ablation plus PVI group. Postoperative recurrence rate and other indicators are analyzed to compare the efficacy and safety between CARTO-Finder-guided ablation plus PVI and MSE-guided ablation plus PVI in patients with persistent atrial fibrillation.

Official Title
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A Randomized Control Trial to Compare the Efficacy and Safety of CARTO-Finder-guided Ablation Plus Pulmonary Vein Isolation and Multiscale Entropy-guided Ablation Plus Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Multiscale entropy-guided ablation plus PVI
* Procedure: CARTO-Finder-guided ablation plus PVI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 80 years old Persistent AF Nonresponse or intolerance to ≥1 antiarrhythmic drug 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CARTO-Finder-guided ablation plus PVI<br>Pulmonary vein circumferential isolation + + ablation of sites recognized by CARTO-Finder module as the core of rotors. | Procedure: CARTO-Finder-guided ablation plus PVI<br>* CARTO-Finder-guided ablation plus PVI<br>|
| Experimental: Multiscale entropy-guided ablation plus PVI<br>Pulmonary vein circumferential isolation + ablation of sites recognized by multiscale entropy analysis as the core of rotors. | Procedure: Multiscale entropy-guided ablation plus PVI<br>* The multiscale entropy is calculated based on intracardiac electrical signals, higher multiscale entropy value indicates closer to the core of rotors which maintains the persistent atrial fibrillation.<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 24 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 24 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 24 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, catheter ablation, CARTO-Finder-guided ablation, Multiscale entropy-guided ablation