A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
propafenone; flecainide; sotalol; dofetilide
Radiofrequency catheter ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Atrial arrhythmia
Eligibility Criteria
Inclusion Criteria:
- Adult patients meeting ACC/AHA criteria for paroxysmal atrial fibrillation (episodes typically last no more than 7 days and are self-terminating)
- Eligible for pulmonary vein isolation
- Able to tolerate antiarrhythmic medication
Exclusion Criteria:
- Age <18
- Persistent or permanent atrial fibrillation (episodes last >7 days and require cardioversion)
- Antiarrhythmic treatment for indication other than atrial fibrillation
- Contraindication or intolerance to all antiarrhythmic medications
- Primary physician unwilling to withhold antiarrhythmic drugs for duration of the study
- Failure to obtain informed consent
Sites / Locations
- Hospital of the University of Pennsylvania
- Presbyterian Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
AAD:YES
AAD:NO
Arm Description
Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.
Subjects do not receive membrane-active anti-arrhythmic medications after ablation.
Outcomes
Primary Outcome Measures
Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug
Secondary Outcome Measures
Freedom From Atrial Arrhythmia at 6 Months Post Procedure.
Full Information
NCT ID
NCT00408200
First Posted
December 1, 2006
Last Updated
January 31, 2013
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT00408200
Brief Title
A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation
Official Title
A Randomized Trial to Assess the Utility of Empirical Anti-Arrhythmic Drug Therapy to Prevent Atrial Arrhythmia During the 6 Weeks Following Pulmonary Vein Isolation to Treat Paroxysmal Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to examine the overall effectiveness of anti-arrhythmic medicines (to control heart rhythm) prescribed after an ablation procedure for atrial fibrillation.
Detailed Description
Atrial fibrillation (AF) is the most common heart rhythm disorder in the US and it is associated with shortness of breath, palpitations, stroke occurrence and increased mortality. Traditional treatment for AF includes anticoagulation, drugs that slow the heart rate and antiarrhythmic agents. More recently, catheter based treatments to address atrial fibrillation have been developed, which involves using radiofrequency energy to isolate the arrhythmogenic foci localized in the pulmonary veins.
During the first weeks following pulmonary vein isolation (PVI), it is not unusual for patients to experience early recurrences of atrial fibrillation or atrial tachycardia due to irritability from the ablation. While these arrhythmias tend to resolve over time, it is nevertheless standard practice to prescribe antiarrhythmic drugs for the first 2-3 months after the intervention to prevent these early recurrences. However, the efficacy of this practice has never been formally evaluated. In addition, we have identified a small group of patients whose atrial tachycardias have terminated after cessation of antiarrhythmic therapy, suggesting that proarrhythmia from these agents may promote reentrant tachycardias in some patients. We therefore designed a study protocol that will evaluate the usefulness of short term antiarrhythmic drug therapy in order to prevent atrial fibrillation and atrial tachycardia episodes during the first 6 weeks following PVI.
The target population of the study includes all patients with paroxysmal atrial fibrillation referred for PVI. After the ablation procedure, patients will be randomized to receive or not receive antiarrhythmic drugs for a period of 6 weeks. Arrhythmia occurrence during this period will be monitored via twice daily transtelephonic monitoring. Clinical visits including a physical exam and 12 lead ECG recording will be scheduled at 6 weeks. The primary endpoint of the study will be a composite endpoint including 1) atrial arrhythmias persisting > 24 hours or requiring initiation of antiarrhythmic therapy 2) need for cardioversion/hospital admission 3) need for repeat ablation or 4) adverse outcome/intolerance of antiarrhythmic agent requiring drug cessation or change during the 6 week follow up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Atrial arrhythmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AAD:YES
Arm Type
Other
Arm Description
Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.
Arm Title
AAD:NO
Arm Type
Other
Arm Description
Subjects do not receive membrane-active anti-arrhythmic medications after ablation.
Intervention Type
Drug
Intervention Name(s)
propafenone; flecainide; sotalol; dofetilide
Intervention Description
Above drugs prescribed per established guidelines for treatment of AF
Intervention Type
Device
Intervention Name(s)
Radiofrequency catheter ablation
Intervention Description
A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.
Primary Outcome Measure Information:
Title
Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Freedom From Atrial Arrhythmia at 6 Months Post Procedure.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients meeting ACC/AHA criteria for paroxysmal atrial fibrillation (episodes typically last no more than 7 days and are self-terminating)
Eligible for pulmonary vein isolation
Able to tolerate antiarrhythmic medication
Exclusion Criteria:
Age <18
Persistent or permanent atrial fibrillation (episodes last >7 days and require cardioversion)
Antiarrhythmic treatment for indication other than atrial fibrillation
Contraindication or intolerance to all antiarrhythmic medications
Primary physician unwilling to withhold antiarrhythmic drugs for duration of the study
Failure to obtain informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward P. Gerstenfeld, MD
Organizational Affiliation
University of Pennsylvania Health System - Cardiac Electrophysiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19738139
Citation
Roux JF, Zado E, Callans DJ, Garcia F, Lin D, Marchlinski FE, Bala R, Dixit S, Riley M, Russo AM, Hutchinson MD, Cooper J, Verdino R, Patel V, Joy PS, Gerstenfeld EP. Antiarrhythmics After Ablation of Atrial Fibrillation (5A Study). Circulation. 2009 Sep 22;120(12):1036-40. doi: 10.1161/CIRCULATIONAHA.108.839639. Epub 2009 Sep 8.
Results Reference
result
PubMed Identifier
21076158
Citation
Leong-Sit P, Roux JF, Zado E, Callans DJ, Garcia F, Lin D, Marchlinski FE, Bala R, Dixit S, Riley M, Hutchinson MD, Cooper J, Russo AM, Verdino R, Gerstenfeld EP. Antiarrhythmics after ablation of atrial fibrillation (5A Study): six-month follow-up study. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):11-4. doi: 10.1161/CIRCEP.110.955393. Epub 2010 Nov 13.
Results Reference
derived
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A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation
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