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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 February 2013
• Main ID: NCT01416935
• Date of registration: 21/03/2011
• Primary sponsor: Inova Health Care Services
• Public title: Necessity of Anti-Arrhythmic Medication After Surgical Ablation for Atrial Fibrillation
• Scientific title: Anti-Arrhythmic Medication (Amiodarone) Post Surgical Ablation for Atrial Fibrillation - Is it Necessary?
• Date of first enrolment: January 2011
• Target sample size: 186
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01416935
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Casey Miller

• Name: Niv Ad, MD
• Affiliation: Inova Health System

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Intervention(s)

Other: No Amiodarone

Primary Outcome(s)

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]

Secondary Outcome(s)

Major Adverse Event Rate [Time Frame: 30 days post-procedure]

Secondary ID(s)

AAM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors