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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00392054
Recruitment Status : Unknown
Verified July 2011 by Population Health Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : October 25, 2006
Last Update Posted : July 22, 2011
Johnson & Johnson
Information provided by:
Population Health Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Pulmonary Vein Isolation performed by Catheter Ablation Drug: Conventional Antiarrhythmic Drug Therapy Phase 3

Detailed Description:

Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice and is estimated to affect 2.2 million people in the United States. AF is a major cause of stroke, adversely affects quality of life, and is associated with increased mortality. Despite advances in antiarrhythmic drug therapy, AF continues to be associated with significant morbidity. Although antiarrhythmic drug therapy is currently considered a first-line option, recent data indicate that more than 35% of Patients will have recurrence of AF despite best antiarrhythmic drug (AAD) therapy, and more than 30% of Patients will discontinue the drugs because of adverse reactions. Furthermore, although recent trials have indicated equivalence of rhythm and rate control strategies in some patient populations, 25-35% of Patients with AF who are rate controlled will continue to have activity limiting symptoms. Newer measures to prevent, treat and potentially cure AF are needed. Seminal work by Haissaguerre and replicated by Chen showed that the majority of AF is initiated by ectopic foci found primarily in the pulmonary veins (PV). Experience with the catheter-based Maze technique led to observations that opened the door to effective and practical catheter-based cures for AF. In response to the difficulties of focal ablation, an alternate strategy has been developed that seeks to electrically isolate the Pulmonary Veins from the atrial tissue. Empirical PV isolation targets all of the PV's without regard to the initiation of ectopic beats. The goal is to create entrance block in the PV. Multipolar circular catheters and basket catheters have been developed that facilitate identification of the electrical connections that are present at the junction of the atrium and the PV, and radiofrequency energy is applied in a circumferential fashion until entrance block is achieved. Relative to focal ablation, circumferential PV isolation is simpler to perform, can be completed without inducing AF, has a shorter procedure time, and has a lower incidence of PV stenosis.

Comparison: Patients will have ablation to achieve entrance and/or exit block into all pulmonary veins, compared with patients receiving antiarrhythmic drugs given in accordance with ACC/AHA/ESC 2006 Guidelines for the Management of patients with AF.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment: A Multi-center Randomized Trial
Study Start Date : August 2006
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Catheter Ablation
Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation
Procedure: Pulmonary Vein Isolation performed by Catheter Ablation
Ablation will be done to achieve entrance block into all pulmonary veins.

Active Comparator: Antiarrhythmic Drug Therapy
Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation
Drug: Conventional Antiarrhythmic Drug Therapy
Anti-Arrhythmic Drugs per ACC/AHA 2006 Guidelines for the Management of Patients with AF

Primary Outcome Measures :
  1. Time to first episode of symptomatic atrial fibrillation [ Time Frame: Assessed during 21 month follow-up period ]
    Time to first recurrence of electrocardiographically documented symptomatic atrial fibrillation lasting >30 seconds during Follow-up Period. The follow-up period begins 90 days after randomization.

  2. Comparison of proportion of patients with an occurrence of any of a cluster of serious complications in either arm [ Time Frame: Assessed during entire 24 month study period ]

    Ablation arm cluster: death, cardiac tamponade, severe PV stenosis>70%, atrioesophageal fistula, thromboembolism, vascular complications (i.e. arterial pseudoaneurysm, arteriovenous fistula and hematoma leading to transfusion), phrenic nerve injury or complete AV block requiring permanent pacemaker implantation.

    Antiarrhythmic drug arm cluster: Death, torsade de pointes, bradycardia leading to pacemaker insertion, syncope, QRS duration prolongation > 50% of baseline, 1:1 atrial flutter or any other significant adverse events that leads to drug discontinuation.

Secondary Outcome Measures :
  1. 1. Total of symptomatic and asymptomatic AF episodes documented by TTM [ Time Frame: During 21 month follow-up period ]
    Patients are assigned a transtelephonic monitoring devide throughout the duration of follow-up and record ECGs whenever experiencing symptoms of AF plus one regular bi-weekly asymptomatic recording. The total of all recorded episodes of atrial fibrillation will be compared.

  2. 2. Quality of life at 1-year follow-up (EQ-5D). [ Time Frame: Measured at baseline, 6 months and 12 months after randomization ]
    The standard EQ-5D questionnaire is completed by study participants.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age > 18 and ≤ 75 years old.
  2. 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:

  1. Documented LVEF <40%.
  2. Documented left atrial diameter >5.5cm.
  3. Moderate to severe LVH (LV wall thickness >1.5cm).
  4. 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.
  5. Documented AF with electrical cardioversion where full therapeutic antiarrhythmic drug therapy after the cardioversion was prescribed.
  6. Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.
  7. 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).
  8. Previous left heart ablation procedure, either by surgery or by percutaneous catheter, for atrial fibrillation.
  9. Current enrollment in another investigational drug or device study.
  10. 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.
  11. Absolute contra-indication to the use of heparin and or warfarin.
  12. Increase risk of bleeding, current peptic ulceration, proliferative diabetic retinopathy, history of severe systemic bleeding, or other history of bleeding diathesis or coagulopathy.
  13. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD).
  14. Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction.
  15. Previous use of full therapeutic dose of an antiarrhythmic drug, including amiodarone, propafenone, flecainide, sotalol, quinidine.
  16. Pacemaker or Implantable Cardioverter Defibrillator.
  17. Women with a positive pregnancy test.
  18. Evidence of active cardiac or systemic infection.
  19. Medical condition limiting expected survival to less than one year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00392054

United States, Texas
Texas Cardiac Arrhythmia Foundation
Austin, Texas, United States, 78705
Austin Heart
Austin, Texas, United States, 78756
Canada, British Columbia
Victoria Cardiac Arrhythmia Trials Inc.
Victoria, British Columbia, Canada, V8R 4R2
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
London Health Sciences Centre University Hospital
London, Ontario, Canada, N6A 5A5
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
McGill University
Montreal, Quebec, Canada, H3G 1A4
Institut Universitaire de Cardiologie et Pneumologie de Québec
Quebec, Canada, G1V 4G5
Czech Republic
Institute for Clinical and Experimental Medicine
Prague, Prague 4, Czech Republic
Charles University
Prague, Czech Republic
Abteilung Rhythmologie
Bad Krozingen, Germany, 79188
Asklepios Klinik St. Georg
Hamburg, Germany, 79188
University Hospital Eppendorf
Hamburg, Germany, D-20246
F. Miulli Hospital
Acquaviva delle Fonti, Bari, Italy, 70021
Sponsors and Collaborators
Population Health Research Institute
Johnson & Johnson
Principal Investigator: Carlos A Morillo, MD Population Health Research Institute, Hamilton Health Sciences Corporation and McMaster University
Principal Investigator: Natale Andrea, MD Texas Cardiac Arrhythmia Research Foundation

Additional Information:
European Heart Rhythm Association; Heart Rhythm Society, Fuster V, Rydén LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Zamorano JL; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation). J Am Coll Cardiol. 2006 Aug 15;48(4):854-906. Erratum in: J Am Coll Cardiol. 2007 Aug 7;50(6):562..

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Andrea Natale, unaffiliated IDE study sponsor, Texas Cardiac Arrhythmia Research Foundation Identifier: NCT00392054     History of Changes
Other Study ID Numbers: USJan13/09CANAug1/06EUJan1/07
First Posted: October 25, 2006    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: July 2011

Keywords provided by Population Health Research Institute:
Atrial Fibrillation
Pulmonary Vein Isolation
Ablation Catheter
Anti-arrhythmic Drug Therapy
First Line Therapy

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents