Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF

Study Overview
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Brief Summary
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The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with isolation of the posterior left atrial wall (PWI) in the region of the pulmonary venous component will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent atrial fibrillation at 12 months, after a single ablation procedure, in comparison to PVI alone. The investigator hypothesizes that the combination of PVI + PWI will result in a significant reduction in recurrence of atrial fibrillation at 12 months after ablation.

Detailed Description
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Patients with persistent atrial fibrillation will be enrolled in this multi-center, randomized, prospective, single-blinded study. After catheter ablation (isolation) of the pulmonary veins (PVI) and while still in the cardiac electrophysiology laboratory, all patients will be randomized to either PVI alone or the combination of PVI + posterior left atrial wall isolation (PWI). For patients randomized to PVI, their ablation procedure will be completed at that time. For those patients randomized to PVI + PWI, they will have additional ablation to achieve PWI. All study patients will have the same follow-up after their ablation procedure, including clinic visits at 3, 6, and 12 months and a heart event monitor for 7-14 days before these visits. An echocardiogram (heart ultrasound) is performed at 6 to 12 months after the ablation. Blood thinners are recommended for two months after ablation and then the need for continued use of blood thinners will be based on individual patient's medical history, stroke risk and the decision of the study doctor. Information about the patients' medical history, heart arrhythmias and atrial fibrillation will be collected during the study which will be analyzed.

Official Title
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Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation (PIVoTAL) - IDE Trial

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Standard Cryoballoon Pulmonary Vein Isolation (PVI)
* Device: Cryoballoon PVI + Posterior Wall Isolation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consistent with the current definitions, all patients with Persistent AF must exhibit an episode of continuous AF that is sustained >7 days. Patients must have symptomatic Persistent AF refractory or intolerant to at least one class I or class III antiarrhythmic drug Males and females with an age >18 years undergoing a first-time catheter ablation of AF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrial flutter) is permitted All patients must understand the requirements of the study and be willing to comply with the post-study follow-up requirements Patients must have documented episode of AF greater than 7 days in the year prior to the procedure Exclusion Criteria: History of long-standing persistent AF Any reversible cause of AF (post-operative, thyroid disorder, etc.) Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months Patients with any corrected or uncorrected congenital heart disease Patients with a history of hypertrophic cardiomyopathy Patients with cardiomyopathy and a left ventricular ejection fraction <40% Congestive heart failure, class IV Left atrial (LA) diameter >55 mm (parasternal long axis view) Patients with left atrial thrombus Women who are known to be pregnant or have had a positive β-HCG (human chorionic gonadotropin) test 7 days prior to procedure Patients whose life expectancy is <1 year History of left-sided left atrial ablation (catheter or surgically-based) Mental impairment precluding the patient from providing informed consent or completing appropriate follow-up

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Cryoballoon Pulmonary Vein Isolation (PVI)<br>Standard cryoballoon pulmonary vein isolation alone using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters | Procedure: Standard Cryoballoon Pulmonary Vein Isolation (PVI)<br>* Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone<br>* Other names: Arctic Front Advance Cardiac Cryoablation System;|
| Experimental: Cryoballoon PVI + Posterior Wall Isolation<br>Cryoballoon pulmonary vein isolation in conjunction with posterior wall isolation using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters | Device: Cryoballoon PVI + Posterior Wall Isolation<br>* Arctic Front Advance Cardiac Cryoballoon Ablation System to ablate the pulmonary veins and the left atrial posterior wall to achieve PVI + posterior wall isolation within the region of the pulmonary venous component<br>* Other names: Arctic Front Advance Cardiac Cryoablation System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month freedom from recurrent atrial fibrillation | Number of participants with recurrent atrial fibrillation following catheter ablation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All atrial arrhythmia recurrences | Number of atrial arrhythmia recurrences after the 90-day blanking period | During a follow-up period of 12 months | 
| Change in Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF) | Change in CCS-SAF from baseline to 12 months | During a follow-up period of 12 months | 
| Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) | Change in AFEQT from baseline to 12 months | During a follow-up period of 12 months | 
| Multiple procedure success | Absence of recurrent atrial arrhythmias after one or more ablation procedure(s) | During a follow-up period of 12 months | 
| Relative reduction in atrial fibrillation burden | Reduction in the burden of atrial fibrillation (in percentage) following catheter ablation | During a follow-up period of 12 months | 
| Freedom from cardioversion for recurrent atrial arrhythmias | Electrical or pharmacological cardioversion for treatment of recurrent atrial arrhythmias not required | During a follow-up period of 12 months | 
| Freedom from repeat atrial fibrillation ablation | Repeat ablation for atrial fibrillation | During a follow-up period of 12 months | 
| Left Atrial Diameter (Size) as predictor of atrial fibrillation recurrence | Change in left atrial diameter (in millimeters) following ablation | During a follow-up period of 12 months | 
| Left Ventricular Ejection Fraction as predictor of atrial fibrillation recurrence | Change in left atrial ejection fraction (in percentage) following ablation | During a follow-up period of 12 months | 
| New York Heart Association Functional Class as predictor of atrial fibrillation recurrence | Change in New York Heart Association Functional Class following ablation | During a follow-up period of 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Catheter ablation, Cryoablation, Cryoballoon, Posterior left atrial wall ablation, Pulmonary vein isolation