Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 Study

Study Overview
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Brief Summary
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This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.

Detailed Description
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A target of 75 participants will be randomised 1:1:1 to one of the three treatment arms. Each participant will have an implantable loop recorder (ILR) prior to ablation in order to assess AF burden. After ablation, each participant will be followed up for a year. The ILR will be used to assess reduction in AF burden.

Official Title
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Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study 2

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: ILR insertion
* Procedure: AF ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic paroxysmal AF suitable for AF ablation Age > 18 years old Informed consent to participate in this study. Exclusion Criteria: Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI-safe. Unable to undergo general anaesthesia for AF ablation. Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery. Scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery. Previous thoracic surgery. Participation in a conflicting study. Potential participants who are mentally incapacitated and cannot consent or comply with follow-up Pregnancy Other cardiac rhythm disorders

Ages Eligible for Study
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Minimum Age: 18 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: Biosense Webster ablation<br>Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation | Device: ILR insertion<br>* Insertion of implantable loop recorder<br>Procedure: AF ablation<br>* AF ablation<br>|
| Active Comparator: Surgical ablation<br>Minimally invasive thoracoscopic surgical AF ablation | Device: ILR insertion<br>* Insertion of implantable loop recorder<br>Procedure: AF ablation<br>* AF ablation<br>|
| Active Comparator: Medtronic ablation<br>Medtronic multi-electrode phased radiofrequency AF ablation | Device: ILR insertion<br>* Insertion of implantable loop recorder<br>Procedure: AF ablation<br>* AF ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF burden | Total proportion of time spent in AF as assessed by ILR | 12 months after ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to AF recurrence | Time to recurrence of any AF after ablation | Up to one year | 
| Time to first symptomatic AF recurrence | Time to first symptomatic AF recurrence as assessed by ILR. | Up to one year | 
| Change in QoL measures | Change in Quality of Life measures assessed by questionnaire. | 12 months after ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Ablation, Implantable loop recorder