Necessity of Anti-Arrhythmic Medication After Surgical Ablation for Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT01416935|
Recruitment Status : Unknown
Verified May 2016 by Inova Health Care Services.
Recruitment status was: Active, not recruiting
First Posted : August 15, 2011
Last Update Posted : May 25, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Other: No Amiodarone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anti-Arrhythmic Medication (Amiodarone) Post Surgical Ablation for Atrial Fibrillation - Is it Necessary?|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||July 2016|
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.
- 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 ]
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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416935
|United States, Virginia|
|Inova Fairfax Hospital|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Niv Ad, MD||Inova Health System|