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

NCT ID: NCT01416935

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2016-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No Amiodarone

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

Group Type: ACTIVE_COMPARATOR

No Amiodarone

Intervention Type: 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.

Amiodarone

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inova Health Care Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niv Ad, MD

Role: PRINCIPAL_INVESTIGATOR

Inova Health Care Services

Locations

Inova Fairfax Hospital

Falls Church, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26253874 (View on PubMed)

Other Identifiers

AAM

Identifier Type: -

Identifier Source: org_study_id