Phase 3
Completed N=127
First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study)
Source: ClinicalTrials.gov NCT00392054 ↗Enrolled (actual)
127
Serious AEs
6.4%
Results posted
Jan 2020
Primary outcomePrimary: Number of Participants With Recurrence of Atrial Tachyarrhythmia — 36; 44 Participants — p=0.0016
◆ Published Evidence
Highly cited
666citations · ~56 / year
Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of paroxysmal atrial fibrillation (RAAFT-2): a randomized trial.
Summary
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.
Linked Publications
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Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of paroxysmal atrial fibrillation (RAAFT-2): a randomized trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Recurrence of Atrial Tachyarrhythmia |
36; 44 | 0.0016 sig |
| PRIMARY Comparison of Proportion of Patients With an Occurrence of Any of a Cluster of Serious Complications in Either Arm |
5; 12 | — |
| SECONDARY Number of Participants With Recurrence of Symptomatic Atrial Tachyarrhythmia |
31; 36 | 0.03 sig |
| SECONDARY Number of Participants With Recurrence of Symptomatic Atrial Fibrillation |
27; 35 | 0.017 sig |
| SECONDARY Episodes of ANY Recurrence of Atrial Tachyarrhythmia |
213; 502 | <0.0001 sig |
| SECONDARY Number of Participants With Recurrence of Atrial Tachyarrhythmia Obtained Clinically |
16; 19 | 0.66 |
| SECONDARY Quality of Life EQ5D Index Score |
1; 1 | — |
| SECONDARY Quality of Life EQ-5D Visual Analog Score |
85; 80 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Documented LVEF 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.
Data sourced from ClinicalTrials.gov (NCT00392054) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.