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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1- No AAD post Ablation | Active Comparator | Subjects will not resume their Anti Arrhythmic Drugs after cryoballoon-ablation for paroxysmal atrial fibrillation. |
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| Arm 2-Resume AAD post Ablation | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No AAD post Ablation. | Other | Subjects will not resume their pre-ablation anti-arrhythmic medications during the 90 following cryo ablation for Atrial Fibrillation |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sultan M Siddique, MD | Prisma Health-Midlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palmetto Health | Columbia | South Carolina | 29203 | United States |
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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 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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