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

Information source: Inova Health Care Services
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation

Intervention: No Amiodarone (Other)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Inova Health Care Services

Official(s) and/or principal investigator(s):
Niv Ad, MD, Principal Investigator, Affiliation: Inova Health System


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.

Clinical Details

Official title: Anti-Arrhythmic Medication (Amiodarone) Post Surgical Ablation for Atrial Fibrillation - Is it Necessary?

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Status of Rhythm Between Baseline and Follow-Up - Recurrence of Atrial Fibrillation

Secondary outcome: Major Adverse Event Rate


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- 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)

Locations and Contacts

Inova Fairfax Hospital, Falls Church, Virginia 22042, United States
Additional Information

Starting date: January 2011
Last updated: March 26, 2015

Page last updated: August 23, 2015

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