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

Purpose

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	Intervention
Atrial Fibrillation	Other: No Amiodarone

Study Type:	Interventional
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?

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Amiodarone Amiodarone hydrochloride

U.S. FDA Resources

Further study details as provided by Inova Health Care Services:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Estimated Enrollment:	186
Study Start Date:	January 2011
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416935

Contacts

Contact: Casey Miller

703.776.7137

casey.miller@inova.org

Locations

United States, Virginia
Inova Fairfax Hospital	Recruiting
Falls Church, Virginia, United States, 22042
Principal Investigator: Niv Ad, MD
Sub-Investigator: Linda Henry, PhD

Sponsors and Collaborators

Inova Health Care Services

Investigators

Principal Investigator:

Niv Ad, MD

Inova Health System

More Information

No publications provided

Responsible Party:	Inova Health Care Services
ClinicalTrials.gov Identifier:	NCT01416935 History of Changes
Other Study ID Numbers:	AAM
Study First Received:	March 21, 2011
Last Updated:	February 19, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Inova Health Care Services:

Atrial Fibrillation
Anti-Arrhythmic Medication

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on June 18, 2013