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

NCT01416935 | Terminated

• 1 other identifier: AAM
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Anti-Arrhythmic Medication

Outcome Measures

Primary Outcomes (1)

• Change in Status of Rhythm Between Baseline and Follow-Up - Recurrence of Atrial Fibrillation

  To demonstrate equality in clinically significant recurrence of AF following ablation while showing superiority for complication and side effect rates in those off Amiodarone vs. those on. •% recurrence AF by telemetry at 3 wks and 24-48 hr Holter monitoring at 6 and 12 wks post procedure, EKG at first visit between 6 and 12 wks post discharge and or ER visit for rapid heart rate in atrial arrhythmia requiring treatment; permanent pacemaker interrogation reports at first follow up visit. •Post-procedure major adverse event rate at 6 mos post-procedure related to side effects of Amiodarone.

  3, 6, 12 weeks and 6 months post-procedure

Secondary Outcomes (1)

• Major Adverse Event Rate

  30 days post-procedure

Study Arms (2)

No Amiodarone

ACTIVE COMPARATOR

Patient will be randomized not to receive to Amiodarone post Cox-Maze procedure unless indicated.

Other: No Amiodarone

Amiodarone

NO INTERVENTION

Patients randomized to receive Amiodarone post Cox-Maze procedure which is our current standard of care.

Interventions

No Amiodarone OTHER

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 Amiodarone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Related Publications (1)

• Ad N, Holmes SD, Shuman DJ, Pritchard G, Miller CE. Amiodarone after surgical ablation for atrial fibrillation: Is it really necessary? A prospective randomized controlled trial. J Thorac Cardiovasc Surg. 2016 Mar;151(3):798-803. doi: 10.1016/j.jtcvs.2015.07.034. Epub 2015 Jul 17.

  PMID: 26253874 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Niv Ad, MD

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: August 15, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: July 1, 2016
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

US (1)