Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP

Study Overview
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Brief Summary
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The purpose of this study is 3 fold:- To compare the efficacy and complication rates of 2 widely used methods, conventional irrigation tip ablation catheter (LASSO) and Ablation Frontiers ablation technology, of AF ablation for PAF. To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter. To accurately evaluate, by continuous rhythm monitoring for 1 year, the efficacy of AF ablation therapy for PAF.

Official Title
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Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Procedure: AF Ablation with Ablation Frontiers Technology
* Procedure: AF Ablation with LASSO catheter
* Device: Reveal XT
* Device: Permanent Dual Chamber Pacemaker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 16-80 years old. Symptomatic PAF with AF episodes self terminating after at least 30 seconds but not longer than 24 hours. Preference is given to patients with AF episodes lasting no longer than 4 hours. PAF should have failed at least one drug therapy medical therapy. Patients must give written informed consent form prior to participating in this study. Exclusion Criteria: Patient is suffering with unstable angina in last 1 week. Patient has had a myocardial infarction within last 2 months. Patient is expecting or has had major cardiac surgery within last 2 months. Patient is participating in a conflicting study. Patient is mentally incapacitated and cannot consent or comply with follow-up. Patient has NYHA class III/ IV heart failure. Patients with severe valvular or ventricular dysfunction. Pregnancy. Patient suffers with other cardiac rhythm disorders. Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings)

Ages Eligible for Study
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Minimum Age: 16 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ablation Frontiers Ablation<br>This group will undergo AF ablation using Ablation Frontiers Technology. | Procedure: AF Ablation with Ablation Frontiers Technology<br>* AF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC.<br>|
| Active Comparator: LASSO ablation<br>This group will undergo atrial fibrillation ablation with traditional LASSO technology | Procedure: AF Ablation with LASSO catheter<br>* AF Ablation with traditional LASSO catheter<br>|
| Active Comparator: Reveal XT monitoring<br>This group will be monitored pre and post ablation using a Reveal XT implantable loop recorder. | Device: Reveal XT<br>* Reveal XT implantable loop recorder monitored group<br>|
| Active Comparator: Permanent Pacemaker - dual chamber<br>This group will be monitored pre and post ablation with a dual chamber permanent pacemaker | Device: Permanent Dual Chamber Pacemaker<br>* This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF Burden | AF Burden post left atrial ablation is defined as the sum of the duration of all atrial tachyarrhythmias expressed as a percentage of the total observation period as assessed by PM Holters. | 12 Months | 
| AF Burden | Comparison of AF burden post PVI ablation using a conventional irrigation tip catheter with LASSO guidance (or equivalent) versus Ablation Frontiers Technology using the PVAC, MASC and TVAC catheters via standard trans-septal techniques. | 12 months | 
| AF Burden detected | To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmia frequency - symptomatic or asymptomatic. | Arrhythmia Frequency is defined as the total number of atrial tachyarrhythmic episodes divided by the observation period, expressed as episodes per day as assessed by PM Holters. | 12 months | 
| Time to first episode of AF | Time to persistent AF is defined as the time from ablation to the first recorded episode of AF | 12 months | 
| Average AF duration | Average arrhythmia duration is defined as the total duration of atrial arrhythmia divided by the total number of atrial arrhythmia episodes. | 12 months | 
| Time to persistent AF. | Time to persistent AF (atrial fibrillation episode lasting for 7 days) | 12 months | 
| Average SR duration. | Average sinus rhythm duration is defined as the total duration of sinus rhythm from first atrial arrhythmic episode until last atrial arrhythmic episode divided by the number of atrial arrhythmic episodes minus 1. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Atrial Fibrillation Ablation, Atrial Fibrillation monitoring, Ablation Frontiers, Reveal XT, LASSO