First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment (RAAFT-3)

Completed · Phase 3

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT04037397

Run by

University of Pennsylvania

People needed

25

Starts

2019-09-24

Expected to finish

2024-10-01

Last updated by the study team

2024-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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