Status:
TERMINATED
Necessity of Anti-Arrhythmic Medication After Surgical Ablation for Atrial Fibrillation
Lead Sponsor:
Inova Health Care Services
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 no...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT01416935
Start Date
January 1 2011
End Date
July 1 2016
Last Update
January 20 2022
Active Locations (1)
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1
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042