Status:
COMPLETED
First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment (RAAFT-3)
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Biosense Webster, Inc.
Texas Cardiac Arrhythmia Research Foundation
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 th...
Eligibility Criteria
Inclusion
- 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:
- Older than 18.
- Symptomatic with persistent AF.
- Experienced at least one AF episode that was documented by surface ECG, 6 months before randomization.
Exclusion
- 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.
- Increase risk of bleeding, current peptic ulceration, proliferative diabetic retinopathy, history of severe systemic bleeding, or other history of bleeding diathesis or coagulopathy.
- Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD).
- Documented intra-atrial thrombus, tumor, or another abnormality, which precludes left atrial catheter ablation.
- Previous use of an antiarrhythmic drug, including amiodarone, propafenone, flecainide, sotalol, quinidine, dofetilide, dronedarone (see below for specifications: Antiarrhythmic Drug Group).
- Women with a positive pregnancy test.
- Evidence of active cardiac or systemic infection.
- Medical condition limiting expected survival to less than one year.
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04037397
Start Date
September 24 2019
End Date
October 1 2024
Last Update
November 12 2024
Active Locations (5)
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1
University of Arizona
Tucson, Arizona, United States, 84724
2
Montefiore Medical Center
The Bronx, New York, United States, 10461
3
MetroHealth
Cleveland, Ohio, United States, 44109
4
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104