Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF

Study Overview
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Brief Summary
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RABLAP-AF will compare pulmonary vein isolation (PVI) in combination with posterior wall isolation (PWI) for patients with persistent atrial fibrillation (AF).

Detailed Description
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Ablation for AF has a high success rate for patients with paroxysmal AF, but success rates for persistent AF remain significantly lower. These patients frequently have more advanced disease in their left atrium than those with paroxysmal AF. A common practice is to perform left atrial PWI in addition to PVI in order to reduce AF recurrence. This approach has conflicting evidence behind it and a large scale clinical trial in those with advanced disease is required. The investigators hope to fill this gap with RABLAP-AF. The investigators will randomise patients with advanced atrial disease 1:1 to PVI+PWI or PVI alone. All patients will receive implantable loop recorders two months prior to the ablation procedure in order to accurately assess the effect of PWI and compare arrhythmia burden before and after ablation.

Official Title
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Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Intracardiac Catheter Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age 18 to 80 (inclusive) Patients with symptomatic advanced persistent AF, defined as: AF which does not spontaneously terminate and requires medical intervention (antiarrhythmics or DCCV) to terminate, AND Recurs following cardioversion, AND Is associated with evidence of left atrial cardiopathy, defined as at least mild left atrial enlargement on imaging (echo, CT or MRI) as defined by standard values (for example British Society of Echocardiography or European equivalent) - in the event of uncertainty, Principal Investigator discretion is allowed. Exclusion Criteria Any previous catheter (or surgical) ablation for AF (previous ablation for atrial flutter or focal atrial tachycardias are allowable) An indwelling atrial septal defect occluder device or anatomical structure that pre-vents free access to the left atrium Severe left ventricular systolic dysfunction (ejection fraction less than 35%) Recent stroke/transient ischaemic attack within 3 months Inability, unwillingness or absolute contraindication to taking an oral anticoagulant medication Severe kidney function impairment (eGFR less than 30ml/min/1.73m2) Morbid obesity with a body mass index ≥40 Extreme frailty (a score of 7,8 or 9 on the Rockwood Clinical Frailty Scale) Severe valvular heart disease of any kind as assessed by the investigator, with or without a prosthetic valve in place Pregnancy

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
Interventional Model Description: A randomised controlled trial with two arms: 1) Pulmonary vein isolation + posterior wall isolation; 2) Pulmonary vein isolation alone
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 - PVI + PWI<br>These patients will receive pulmonary vein isolation and posterior wall isolation. | Procedure: Intracardiac Catheter Ablation<br>* Both arms will receive intracardiac catheter ablation procedures as described.<br>|
| Other: Group 2 - PVI only<br>These patients will receive pulmonary vein isolation only. | Procedure: Intracardiac Catheter Ablation<br>* Both arms will receive intracardiac catheter ablation procedures as described.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first day with ATA burden of 12 hours or greater | Time to day with atrial tachyarrhythmia burden lasting 12 hours or greater, following a 3 month blanking period post-ablation | From 3 months post ablation to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first day with ATA burden of 24 hours | Time to first day with atrial tachyarrhythmia burden of 24 hours, following a 3 month blanking period post-ablation | From 3 months post ablation to 12 months | 
| Time to first day with ATA burden of 60 minutes or greater | Time to first day with atrial tachyarrhythmia burden of 60 minutes or greater, following a 3 month blanking period post-ablation | From 3 months post ablation to 12 months | 
| Number of patients with >= 75% reduction in cumulative burden of AF between pre-ablation and months 3-12 | AF burden (assessed by loop recorder) will be analysed in the 2 months pre-ablation and compared with the 9 months post-blanking period. This outcome will assess the number of patients who achieve greater than or equal to 75% reduction. | 12 months | 
| Reduction in burden of AF between pre-ablation and months 3-12 | AF burden (assessed by loop recorder) will be analysed in the 2 months pre-ablation and compared with the 9 months post-blanking period. This outcome will assess the average % reduction in AF burden between these time periods. | 12 months | 
| Difference in AFEQT questionnaire between baseline and month 12 | Differences in quality of life indicators as measured by the AF Effect on QualiTy of life survey (AFEQT) between baseline and 12 month follow-up | 12 months | 
| Difference in EQ5D questionnaire between baseline and month 12 | Differences in quality of life indicators as measured by the EuroQol 5 Dimension survey (EQ5D) questionnaire between baseline and 12 month follow-up | 12 months | 
| Difference in VAS between baseline and month 12 | Differences in quality of life indicators as measured by Visual Analogue Scale (VAS) between baseline and 12 month follow-up | 12 months | 
| Use of antiarrhythmic drugs from month 3 onwards | Number of patients requiring antiarrhythmic drugs following the 3 month blanking period. | From 3 months post ablation to 12 months | 
| Use of direct current cardioversion or repeat ablation | Number of patients requiring cardioversion or repeat ablation | From 3 months post ablation to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Posterior wall isolation, Ablation, Persistent Atrial Fibrillation