Necessity of Anti-Arrhythmic Medication After Surgical Ablation for Atrial Fibrillation
The purpose of this study is to determine whether anti arrhythmic medication, specifically Amiodarone, is required during the first three months post surgical ablation.
Hypothesis: Amiodarone will not be required during the first three months as verified by no increase in rehospitalizations for recurrent Atrial Fibrillation, and report of sinus rhythm at surgical follow up (approximately 3 weeks from date of surgery), 6 weeks and 12 weeks to include patients' first follow up with cardiologist at approximately 3 months post surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Anti-Arrhythmic Medication (Amiodarone) Post Surgical Ablation for Atrial Fibrillation - Is it Necessary?|
- Change in Status of Rhythm Between Baseline and Follow-Up - Recurrence of Atrial Fibrillation [ Time Frame: 3, 6, 12 weeks and 6 months post-procedure ] [ Designated as safety issue: No ]
To demonstrate equality in clinically significant recurrence of AF following ablation while showing superiority for complication and side effect rates in those off Amiodarone vs. those on.
•% recurrence AF by telemetry at 3 wks and 24-48 hr Holter monitoring at 6 and 12 wks post procedure, EKG at first visit between 6 and 12 wks post discharge and or ER visit for rapid heart rate in atrial arrhythmia requiring treatment; permanent pacemaker interrogation reports at first follow up visit.
•Post-procedure major adverse event rate at 6 mos post-procedure related to side effects of Amiodarone.
- Major Adverse Event Rate [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: No ]To characterize the composite post-procedure major adverse event rate (pericardial/ pleural effusion with elevated INR, hemorrhagic stroke with elevated INR, thromboembolic stroke) within 30 days post-procedure or prior to hospital discharge whatever comes last
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||July 2016|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Active Comparator: No Amiodarone
Patient will be randomized not to receive to Amiodarone post Cox-Maze procedure unless indicated.
Other: No Amiodarone
This is a randomized study whereby patients who would routinely/usually be scheduled to receive Amiodarone as their anti-arrhythmic medication post surgical ablation will be randomly assigned to receive Amiodarone or no Amiodarone, but all other medications would remain as prescribed for patients following surgical ablation which will include beta blockade therapy unless contraindicated which is an American Heart Associated and Heart Rhythm Society recognized treatment.
No Intervention: Amiodarone
Patients randomized to receive Amiodarone post Cox-Maze procedure which is our current standard of care.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416935
|United States, Virginia|
|Inova Fairfax Hospital|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Niv Ad, MD||Inova Health System|