Necessity of Anti-Arrhythmic Medication After Surgical Ablation for Atrial Fibrillation

Anti-Arrhythmic Medication (Amiodarone) Post Surgical Ablation for Atrial Fibrillation - Is it Necessary?

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 Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: No Amiodarone

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is ≥ 18 years of age
• Subject must be diagnosed with Persistent and/or Longstanding Persistent Atrial fibrillation as classified by the HRS Guidelines 8 [0]
• Subject must be selected as a candidate to undergo the Cox- Maze procedure for ablation of atrial fibrillation
• The Cox Maze procedure may be done as a stand alone procedure or combined with other cardiac surgical procedures either via a median sternotomy or a right thoracotomy:
• Subject has a Left Ventricular Ejection Fraction (LVEF) ≥ 30%
• Subject would normally be prescribed Amiodarone as an anti arrhythmic medication post surgical ablation
• Subject is able and willing to provide written informed consent and HIPAA authorization
• Subject is able and willing to comply with all study requirements including attending all follow-up visits as deemed necessary by personal physician (cardiologist)
• Subject has a life expectancy of at least one year

Exclusion Criteria:

• Subject has undergone previous attempts at surgical Maze procedure or other AF operation, including surgical or catheter ablation Subject has an accessory pathways disorder (e.g. Wolff-Parkinson-White syndrome)
• Subject is in Class IV NYHA
• Subject has had a documented MI within 6 weeks prior to study enrollment
• Subject needs emergent cardiac surgery (i.e. cardiogenic shock)
• Subject has known carotid artery stenosis greater than 80%
• Subject has a current diagnosis of active systemic infection
• Subject is pregnant, planning to become pregnant within 12-14 months, or lactating
• Subject requires preoperative intra-aortic balloon pump or intravenous inotropes
• Subject has renal failure requiring dialysis
• Subject is diagnosed with hepatic failure
• Subject is on anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
• Subject has a known connective tissue disorder
• Subject is incarcerated
• Subject has previous or current therapy that could compromise tissue integrity including thoracic radiation, chemotherapy, long-term oral or injected steroids
• Subject is an intravenous drug and/or alcohol abuser
• Subject is participating in concomitant research studies of investigational products ( e.g. Appendage closure devices, atrial septal defect patches)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Status of Rhythm Between Baseline and Follow-Up - Recurrence of Atrial Fibrillation	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.	3, 6, 12 weeks and 6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Event Rate	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	30 days post-procedure

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Investigators: Principal Investigator: Niv Ad, MD, Inova Health Care Services

Publications and helpful links

General Publications

• Ad N, Holmes SD, Shuman DJ, Pritchard G, Miller CE. Amiodarone after surgical ablation for atrial fibrillation: Is it really necessary? A prospective randomized controlled trial. J Thorac Cardiovasc Surg. 2016 Mar;151(3):798-803. doi: 10.1016/j.jtcvs.2015.07.034. Epub 2015 Jul 17.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: March 21, 2011
• First Submitted That Met QC Criteria: August 12, 2011
• First Posted (Estimate): August 15, 2011

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Anti-Arrhythmic Medication
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Potassium Channel Blockers; Amiodarone
• Other Study ID Numbers: AAM