The purpose of this study is to determine if catheter-based atrial fibrillation (AF) ablation is superior to treatment with antiarrhythmic drugs as a first-line therapy for symptomatic persistent AF.
The burden of atrial fibrillation (AF) on Western countries healthcare systems is steadily increasing, with over 2 million Americans and 4 million Europeans affected by this condition. It is by far the most common sustained arrhythmia encountered in clinical practice, with a striking impact on morbidity and mortality. Achieving a definite cure is highly desirable, as this would have profound social and economic implication. In patients with drug-refractory paroxysmal AF, multiple clinical trials have established the superiority of catheter ablation over further antiarrhythmic drug (AAD) therapy for the long-term maintenance of sinus rhythm, to improve quality of life, and reduce hospitalizations. Recent randomized controlled trials have also demonstrated a beneficial role of catheter ablation as a first-line therapy in patients with paroxysmal AF, with significantly better arrhythmia control and improved quality of life compared to AAD therapy. Patients with symptomatic persistent AF represent a more challenging group to treat, given the overall lower success rate of catheter ablation procedures in this group of patients. Pharmacologic rhythm-control strategies are also less effective in persistent AF, with a substantially increased economic burden given the repeat admissions for electrical cardioversions and AAD initiation/titration. In patients with symptomatic persistent AF who have already failed AADs, catheter ablation has been shown superior to further AAD therapy for sinus rhythm restoration in a recent randomized controlled trial. However, the value of an upstream adoption of catheter ablation for the treatment of symptomatic persistent AF (i.e., before a trial with AADs) is unknown. The purpose of the third Radiofrequency Ablation vs Antiarrhythmic Drugs for Atrial Fibrillation Treatment (RAAFT-3) trial is to determine whether catheter ablation is superior to AAD as a first-line therapy in patients with persistent AF who had not been exposed to antiarrhythmic treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Propafenone or Flecanide or Sotalol or Dofetilide or Dronedarone or Amiodarone. The subject must first fail a Class 1C or III drug prior to starting Amiodarone
Approved Biosense Webster Inc. catheter devices should be used to perform RFCA. Ablation will be done to achieve entrance block into all pulmonary veins
University of Arizona
Tucson, Arizona, United States
Montefiore Medical Center
The Bronx, New York, United States
MetroHealth
Cleveland, Ohio, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Recurrence of symptomatic Atrial Fibrillation
Recurrence (post 90- day blanking period) of symptomatic or asymptomatic AF, atrial flutter, or atrial tachycardia lasting more than 30 seconds documented by the pre-defined ECG monitoring is the primary efficacy outcome. Any episodes occurring during the 90-day blanking period are not considered as recurrences
Time frame: 18 Months
Time to AF recurrence
Time to first documented recurrence of AF, atrial flutter, and atrial tachycardia episodes
Time frame: 18 Months
Repeat Episodes of AF
Repeated episodes (≥2) of symptomatic or asymptomatic AF, atrial flutter, and atrial tachycardia episodes
Time frame: 18 Months
AF/AT Burden
Cumulative AF/AT burden (defined as percentage of time in AF/AT during follow-up)
Time frame: 18 Months
CV Hospitalizations
Hospitalization for cardiovascular and non-cardiovascular causes during follow-up
Time frame: 18 Months
Quality of Life Questionnaire
Quality of life at the 1-year follow-up by SF-36
Time frame: 18 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Pennsylvania
Philadelphia, Pennsylvania, United States