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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No Amiodarone
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Anti-Arrhythmic Medication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Inova Fairfax Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

No Amiodarone

Amiodarone

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Major Adverse Event Rate
To characterize the composite post-procedure major adverse event rate (pericardial/ pleural effusion with elevated INR, hemorrhagic stroke with elevated INR, thromboembolic stroke) within 30 days post-procedure or prior to hospital discharge whatever comes last

Full Information

First Posted
March 21, 2011
Last Updated
January 5, 2022
Sponsor
Inova Health Care Services
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1. Study Identification

Unique Protocol Identification Number
NCT01416935
Brief Title
Necessity of Anti-Arrhythmic Medication After Surgical Ablation for Atrial Fibrillation
Official Title
Anti-Arrhythmic Medication (Amiodarone) Post Surgical Ablation for Atrial Fibrillation - Is it Necessary?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Study Start Date
January 1, 2011 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Anti-Arrhythmic Medication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Amiodarone
Arm Type
Active Comparator
Arm Description
Patient will be randomized not to receive to Amiodarone post Cox-Maze procedure unless indicated.
Arm Title
Amiodarone
Arm Type
No Intervention
Arm Description
Patients randomized to receive Amiodarone post Cox-Maze procedure which is our current standard of care.
Intervention Type
Other
Intervention Name(s)
No Amiodarone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Status of Rhythm Between Baseline and Follow-Up - Recurrence of Atrial Fibrillation
Description
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.
Time Frame
3, 6, 12 weeks and 6 months post-procedure
Secondary Outcome Measure Information:
Title
Major Adverse Event Rate
Description
To characterize the composite post-procedure major adverse event rate (pericardial/ pleural effusion with elevated INR, hemorrhagic stroke with elevated INR, thromboembolic stroke) within 30 days post-procedure or prior to hospital discharge whatever comes last
Time Frame
30 days post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niv Ad, MD
Organizational Affiliation
Inova Health Care Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26253874
Citation
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.
Results Reference
derived

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

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