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Earlier studies have shown a dose-dependent relationship between alcohol intake and incident atrial fibrillation (AF) as well as a causal link with several risk factors for AF such as hypertension, obesity and sleep apnea. However, the effect of drinking (alcohol) on post-ablation outcome such as arrhythmia recurrence, quality of life (QoL) and cognitive function in AF patients is unclear. Therefore, we aim to find the answer for a very frequently asked question, "is it safe to continue drinking alcohol (at the pre-ablation level) following catheter ablation OR should the intake be reduced for better outcome?", in this randomized trial.
Study period will start from the day after the procedure and continue for 8 months (2-month blanking period+ 6 months follow-up).
Group 1: Complete abstinence or ≤2 drinks/week in group 1 during the study period Group 2: Allowed to continue their pre-ablation drinking habit
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study | Active Comparator | Complete abstinence or ≤2 drinks/week in group 1 during the study period |
|
| Control | Active Comparator | Allowed to continue their pre-ablation drinking habit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study arm | Behavioral | Participants will be asked to completely abstain from drinking or consume 2 or less drinks per week for 8 months following catheter ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmia recurrence | Arrhythmia recurrence across all AF types at 8 months after the ablation procedure, off- or on-antiarrhythmic drug (AAD) | 8 months after the ablation procedure for AF |
| Measure | Description | Time Frame |
|---|---|---|
| Change in QoL | Change in QoL measured by AFEQT survey at baseline and 6 months | 6 months after the blanking period of 2 months |
| Change in cognitive function | Change in cognitive function measured by MoCA survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Natale | Contact | 5125448186 | dr.natale@gmail.com | |
| Sanghamitra Mohanty | Contact | 5127842651 | mitra1989@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Natale | Texas Cardiac Arrhythmia Institute, St. | Principal Investigator |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Paroxysmal and Persistent AF patients undergoing their first catheter ablation will be screened for eligibility and those that meet the criteria and consent to participate will be randomly assigned to group 1 or 2.
Study period will start from the day after the procedure and continue for 8 months (2-month blanking period+ 6 months follow-up).
Group 1: Complete abstinence or ≤2 drinks/week in group 1 during the study period Group 2: Allowed to continue their pre-ablation drinking habit
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| 6 months after the blanking period of 2 months |
| Arrhythmia burden | Arrhythmia burden at follow-up | 6-8 months following ablation |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |