First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment
Overview
- Phase
- Phase 3
- Intervention
- Anti Arrhythmics
- Conditions
- Atrial Fibrillation
- Sponsor
- University of Pennsylvania
- Enrollment
- 25
- Locations
- 5
- Primary Endpoint
- Recurrence of symptomatic Atrial Fibrillation
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligible patients have a history of persistent AF with at least 2 episodes in the 9 months prior to enrollment. Persistent AF is defined according to 2014 AHA/ACC/HRS guidelines as continuous AF that is sustained for more than 7 days.Patients are enrolled if they are:
- •Symptomatic with persistent AF.
- •Experienced at least one AF episode that was documented by surface ECG, 6 months before randomization.
Exclusion Criteria
- •Documented LVEF \<40%.
- •Documented left atrial diameter \>/=6cm.
- •Moderate to severe LVH (LV wall thickness \>1.5cm).
- •Documented severe valvular disease (aortic stenosis, mitral regurgitation, tricuspid regurgitation or presence of mechanical cardiac valves), active coronary artery disease (defined as the presence of \>70% stenosis of coronary arteries or documentation of active myocardial ischemia), recent (within 6 months) CABG.
- •Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.
- •Contraindication for the use of all antiarrhythmic drugs including sotalol, dofetilide, amiodarone and 1C antiarrhythmic drugs (liver enzymes and serum creatinine that are outside the upper normal lab values, e.g. \> 3 times ULN with 2 abnormal lab values). \[Note: Participants will not be excluded if they are able to take any single or combination of drugs without contraindications\]
- •Previous left heart ablation procedure, either by surgery or by percutaneous catheter, for atrial fibrillation.
- •Current enrollment in another investigational drug or device study.
- •Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the Patient for the entire study period.
- •Absolute contra-indication to the use of heparin and or oral anticoagulation.
Arms & Interventions
Antiarrhythmic Medications
Patients randomized to the antiarrhythmic drug group are administered medications approved for treatment of AF by the regulatory bodies of each participating country. The selection of antiarrhythmic drugs and dosages is left to the discretion of the investigator, and will follow the AHA/ACC/HRS general guidelines
Intervention: Anti Arrhythmics
Radio Frequency Catheter Ablation
Patients randomized to radiofrequency catheter ablation will undergo isolation of the pulmonary veins with confirmation of entrance block into each vein. The CARTO TM(Biosense Webster, CA) system will be used to reconstruct the atrial geometry and assist for mapping and ablation. Ablation will be performed using approved ablation devices (Biosense Webster, CA).
Intervention: Pulmonary Vein Isolation performed by Radio Frequency Catheter Ablation
Outcomes
Primary Outcomes
Recurrence of symptomatic Atrial Fibrillation
Time Frame: 18 Months
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
Secondary Outcomes
- CV Hospitalizations(18 Months)
- Time to AF recurrence(18 Months)
- Repeat Episodes of AF(18 Months)
- Quality of Life Questionnaire(18 Months)
- AF/AT Burden(18 Months)