Pulmonary Vein Antrum Isolation (PVAI) Plus Scar Homogenization and Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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This study aims to examine the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation patients using different ablation strategies such as : (i) pulmonary vein antrum isolation (PVAI) + isolation of left atrial posterior wall, (ii) PVAI plus scar homogenization, (iii) PVAI plus isolation of posterior wall plus ablation of non-PV triggers [ PVAI: Pulmonary Vein Antrum Isolation Non-PV triggers: Triggers arising from sites other than pulmonary veins]

Detailed Description
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Back ground: Pulmonary vein antrum isolation (PVAI) as a lone procedure, is known to have limited success rate in terms of long-term recurrence-free survival in non-paroxysmal atrial fibrillation (NPAF) and additional ablations isolating extra-PV triggers seem to improve the outcome (1). The extra-PV triggers include triggers from other sites such as left atrial posterior wall, superior vena cava, interatrial septum, crista terminalis, left atrial appendage and coronary sinus (1, 2). These are known to be independent predictors of late AF recurrence following catheter ablation (3, 4, and 5). Earlier studies have demonstrated better ablation outcome in NPAF when non-PV triggers sites were isolated along with PVAI (5, 6). Moreover, Verma et al had reported high (57%) recurrence rate post-index procedure in AF patients with pre-existent scar (7). However, published data are conflicting regarding the benefits of additional substrate guided ablation (scar homogenization) compared to conventional PVAI alone strategy (8). Also, limited data is available showing a comparison of the lasting efficacy of the above three procedures when used in different combinations. Hypothesis: The combined ablation strategy including PVAI, scar homogenization and ablation of extra-PV triggers has the highest likelihood of maintaining long-term sinus rhythm in patients with NPAF.

Official Title
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PVAI Plus Scar Homogenization and Ablation of Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation

Conditions
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Persistent Atrial Fibrillation, Long-standing Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Pulmonary Vein Antrum Isolation
* Procedure: scar homogenization
* Procedure: Non-PV triggers ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patients undergoing first catheter ablation for drug-refractory Persistent (PerAF) or long-standing persistent AF (LSPAF) Ability to understand and provide signed informed consent Exclusion Criteria: Previous catheter ablation or MAZE procedure in left atrium Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Pulmonary Vein Antrum Isolation (PVAI) + isolation of left atrial posterior wall | Procedure: Pulmonary Vein Antrum Isolation<br>* Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall<br>* Other names: PVAI;|
| Active Comparator: Study I<br>PVAI+ scar homogenization | Procedure: Pulmonary Vein Antrum Isolation<br>* Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall<br>* Other names: PVAI;Procedure: scar homogenization<br>* PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.<br>|
| Active Comparator: Study II<br>PVAI + isolation of left atrial posterior wall + non-PV triggers ablation | Procedure: Pulmonary Vein Antrum Isolation<br>* Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall<br>* Other names: PVAI;Procedure: scar homogenization<br>* PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.<br>Procedure: Non-PV triggers ablation<br>* PVAI + Isolation of LA posterior wall + Catheter ablation of triggers originating from extra-PV sites<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial arrhythmia | Any episode of AF/AT (atrial tachycardia) longer than 30 seconds will be considered as recurrence). Episodes that occur during the first 3 months of the procedure (blanking period) will not be considered as recurrence. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in quality of life | Improvement in quality of life | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PVAI, NPAF, Non-PV triggers