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

Inova Health Care Services

Status

Terminated

Conditions

Atrial Fibrillation

Treatments

Other: No Amiodarone

Study type

Interventional

Funder types

Other

Identifiers

NCT01416935

AAM

Details and patient eligibility

About

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.

Enrollment

186 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)