First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study)

Completed · Phase 3

Conditions studied: Atrial Fibrillation

In brief

The purpose of this study is to determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of antiarrhythmic drugs.

Key facts

Study ID

NCT00392054

Run by

Population Health Research Institute

People needed

127

Starts

2006-08-01

Expected to finish

2012-02-01

Last updated by the study team

2020-01-31

Who can join

Age: 19 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 and ≤ 75 years old.
• Symptomatic, recurrent paroxysmal AF lasting > 30 seconds (at least 4 episodes within the prior 6 months). At least one episode must be documented by Holter,12-lead ECG, event monitor or rhythm strip.

You may not qualify if…

• Documented LVEF <40%.
• Documented left atrial diameter >5.5cm.
• Moderate to severe LVH (LV wall thickness >1.5cm).
• Documented valvular disease, coronary heart disease (defined as the presence of >70% stenosis of coronary arteries or documentation of active myocardial ischemia), post-CABG, postoperative cardiac surgery or peripheral artery disease.
• Documented AF with electrical cardioversion where full therapeutic antiarrhythmic drug therapy after the cardioversion was prescribed.
• Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.
• Contraindication for the use of sotalol, dofetilide 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).
• 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 warfarin.
• 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 catheter introduction.
• Previous use of full therapeutic dose of an antiarrhythmic drug, including amiodarone, propafenone, flecainide, sotalol, quinidine.
• Pacemaker or Implantable Cardioverter Defibrillator.
• 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

• Texas Cardiac Arrhythmia Foundation — Austin, Texas, United States
• Austin Heart — Austin, Texas, United States
• Victoria Cardiac Arrhythmia Trials Inc. — Victoria, British Columbia, Canada
• Hamilton General Hospital — Hamilton, Ontario, Canada
• London Health Sciences Centre University Hospital — London, Ontario, Canada
• Southlake Regional Health Centre — Newmarket, Ontario, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada
• McGill University — Montreal, Quebec, Canada
• Institut Universitaire de Cardiologie et Pneumologie de Québec — Québec, Canada
• Institute for Clinical and Experimental Medicine — Prague, Prague 4, Czechia
• Charles University — Prague, Czechia
• Abteilung Rhythmologie — Bad Krozingen, Germany
• Asklepios Klinik St. Georg — Hamburg, Germany
• University Hospital Eppendorf — Hamburg, Germany
• F. Miulli Hospital — Acquaviva delle Fonti, Bari, Italy

Full record on ClinicalTrials.gov

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