Assess Differences in Pain Following Cryo and Radiofrequency Atrial Fibrillation Ablation

Study Overview
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Brief Summary
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The primary objective is to assess any differences in patient quality of life between Cryo Balloon ablation and Radiofrequency ablation in the treatment of atrial fibrillation. The study will also assess any differences in the amount and duration of pain medication required after the ablation.

Detailed Description
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Currently there are several different accepted techniques for performing ablation of atrial fibrillation. The two primary techniques currently in use in our center for atrial fibrillation are Cryo Balloon and Radiofrequency ablation. Based on personal observation, it is felt that patients undergoing Radiofrequency ablation have a higher incidence of chest discomfort and subsequently a greater requirement for pain medications post procedure as compared to those patients undergoing Cryo ablation.

Official Title
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A Prospective Comparison of Quality of Life Following Atrial Fibrillation Ablation Using the Arctic Front Advance Cryo Balloon Compared to Contact Force Sensing Radiofrequency Catheter Ablation

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Paroxysmal atrial fibrillation who are advised either Cryoablation or Radiofrequency ablation for treatment. Exclusion Criteria: Persistent atrial fibrillation Pregnant Taking pain medications for acute or chronic conditions at the time of the procedure. Undergo a combination of Cryoablation and Radiofrequency ablation Radiofrequency group who undergo ablation beyond pulmonary vein isolation

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cryo Balloon Ablation<br>Arctic Front Advance Cryo Balloon: Mode of ablation determined based on patient and physician preference | |
| Radiofrequency Ablation<br>Contact Force Sensing Radiofrequency Catheter Ablation: Mode of ablation determined based on patient and physician preference | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Measurement | Self report pain intensity measured at baseline and then once a day beginning at least four hours after the ablation. Three individual pain scales will be used. Universal Pain Assessment Tool is scored 0 to 10 with 0 = no pain and 10 = severe. | 7 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Status and Activity Measurement | Self report health status and activity measured at baseline and then once a day beginning at least four hours after the ablation using SF-36 Health and Well-Being Questionnaire. | 7 Days | 
| Pain Medication Assessment | Assess amount and duration of pain medication required post ablation | 30 Days |