Comparison of Recurrence of Atrial Fibrillation Post Cryoballon Ablation During the 90-day Blanking Period-with and Without Anti-arrhythmic Drug Therapy

Study Overview
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Brief Summary
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This study is being done to find out if patients taking Anti Arrhythmia Drugs (AADs) after cryoballoon ablation for atrial fibrillation, compared to patients who do not take Anti- Arrhythmic Drugs after an ablation affect Atrial Fibrillation from coming back. The study will also look at the side effects of the AADs.

Detailed Description
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Pulmonary vein isolation (PVI) is a cornerstone ablation strategy used in the management of paroxysmal atrial fibrillation (PAF), and it is a class IA indication for anti-arrhythmic drug (AAD) refractory symptomatic PAF. However, the consensus statements are vague about the utility of AAD management during the 90-day blanking window post-PVI. Moreover, there is no specific guidance to cryoballoon users on the usage of AADs during the 90-day blanking period that exists anywhere in the published literature. Simply, these studies have not been conducted with the cryoballoon procedure.

Official Title
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Monitoring Safety and Recurrence of Paroxysmal Atrial Fibrillation After 1st Cryo-balloon Ablation With and Without Antiarrhythmic Drug Therapy During the 90-day Blanking Period - Examined With Adverse Event Monitoring and Cardiovascular Implantable Electronic Devices (CIEDs)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: No AAD post Ablation.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Drug refractory and recurrent Paroxysmal Atrial Fibrillation The subject meets medical criteria for cryoballoon ablation to treat Paroxysmal AF Age 18 to 80 years The subject has a Cardiovascular Implantable Electronic Device (CIED) that captures AF episodes, such as an implantable loop recorder, pacemaker, or implantable cardioverter defibrillator (ICD) with a properly functioning atrial lead. Exclusion Criteria: Use of any Anti- Arrhythmic Drugs for ventricular arrhythmias Ejection Fraction (EF)<45% Prior A. Fib. ablation Pregnant women

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1- No AAD post Ablation<br>Subjects will not resume their Anti Arrhythmic Drugs after cryoballoon-ablation for paroxysmal atrial fibrillation. | Other: No AAD post Ablation.<br>* Subjects will not resume their pre-ablation anti-arrhythmic medications during the 90 following cryo ablation for Atrial Fibrillation<br>* Other names: No AAD;|
| No Intervention: Arm 2-Resume AAD post Ablation<br>Subjects will resume their pre-ablation Anti Arrhythmic Drugs after cryoballoon-ablation for paroxysmal atrial fibrillation, during the 90 day blanking period following the ablation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare recurrence, recurrence rate, burden of atrial fibrillation post ablation between the two groups. | Rhythm status through implantable loop recorder (or pacemaker with functioning atrial lead) at 3 month, 6 month, 12 month compared between two treatment groups, including: A) AF burden (Average amount of time in AF per day) B) AF recurrence rate (Frequency of AF, occurrences per day) C) Time to AF recurrence | 12 months | 
| Symptom Assessments | Symptom assessments by clinical follow up and phone calls, including symptom severity score using the Severity of Atrial Fibrillation Scale between the two groups. | 12 months | 
| Adverse Events Assessments | Ongoing assessment of adverse events in both arms of the study, including AADs side effects in 90-day blanking period. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cost of AADs during the 90-day blanking period. | The cost of AADs during the 90-day blanking period. | 12 months | 
| Assess the rate of hospitalizations, emergency room visits, and unscheduled cardiology visits for the treatment of AF between the two groups | A) Event during the 90-day blanking period will be assessed for AAD related and unrelated adverse events that caused the cardiac related visit | 12 months | 
| The differential usage of anticoagulation therapy between two arms. | The differential usage of anticoagulation therapy between two arms. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiarrhythmic Agents, Catheter Ablation, electric, Cardiac Arrhythmias, Anti-Arrhythmia Drugs