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Sponsored by: |
University of Pennsylvania |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00408200 |
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.
Condition | Intervention |
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Atrial Fibrillation |
Drug: propafenone; flecainide; sotalol; dofetilide Device: Radiofrequency catheter ablation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 168 |
Study Start Date: | November 2006 |
Study Completion Date: | June 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AAD:YES
Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.
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Drug: propafenone; flecainide; sotalol; dofetilide
Above drugs prescribed per established guidelines for treatment of AF
Device: Radiofrequency catheter ablation
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.
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AAD:NO
Subjects do not receive membrane-active anti-arrhythmic medications after ablation.
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Device: Radiofrequency catheter ablation
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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Presbyterian Medical Center | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Edward P. Gerstenfeld, MD | University of Pennsylvania Health System - Cardiac Electrophysiology |
Study ID Numbers: | 805346HUP |
Study First Received: | December 1, 2006 |
Last Updated: | August 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00408200 History of Changes |
Health Authority: | United States: Institutional Review Board |
Atrial fibrillation Atrial arrhythmia |
Propafenone Heart Diseases Potassium Channel Blockers Flecainide Dofetilide |
Cardiovascular Agents Anti-Arrhythmia Agents Atrial Fibrillation Sotalol Arrhythmias, Cardiac |
Heart Diseases Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Pharmacologic Actions Membrane Transport Modulators Pathologic Processes Propafenone |
Therapeutic Uses Dofetilide Potassium Channel Blockers Cardiovascular Diseases Atrial Fibrillation Anti-Arrhythmia Agents Arrhythmias, Cardiac |