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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Inova Health Care Services

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT01416935

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United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Inova Health Care Services
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Principal Investigator: Niv Ad, MD Inova Health System
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Inova Health Care Services Identifier: NCT01416935    
Other Study ID Numbers: AAM
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016
Keywords provided by Inova Health Care Services:
Atrial Fibrillation
Anti-Arrhythmic Medication
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors