Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatment no amiodarone
Sponsor Inova Health Care Services
Start date January 2011
End date January 2015
Trial size 186 participants
Trial identifier NCT01416935, AAM

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patient will be randomized not to receive to Amiodarone post Cox-Maze procedure unless indicated.
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)
Patients randomized to receive Amiodarone post Cox-Maze procedure which is our current standard of care.

Primary Outcomes

Measure
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 Outcomes

Measure
Major Adverse Event Rate
time frame: 30 days post-procedure

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Anti-Arrhythmic Medication (Amiodarone) Post Surgical Ablation for Atrial Fibrillation - Is it Necessary?
Principal investigator Niv Ad, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Inova Health Care Services.