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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Inova Health Care Services
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT01416935
First received: March 21, 2011
Last updated: February 19, 2014
Last verified: February 2014
  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:


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 2015
Estimated Primary Completion Date: January 2015 (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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 2014
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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 24, 2014