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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Population Health Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT00392054
First received: October 23, 2006
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Atrial Fibrillation
Procedure: Pulmonary Vein Isolation performed by Catheter Ablation
Drug: Conventional Antiarrhythmic Drug Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment: A Multi-center Randomized Trial

Resource links provided by NLM:


Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • Time to first episode of symptomatic atrial fibrillation [ Time Frame: Assessed during 21 month follow-up period ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]

    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. Total of symptomatic and asymptomatic AF episodes documented by TTM [ Time Frame: During 21 month follow-up period ] [ Designated as safety issue: No ]
    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. Quality of life at 1-year follow-up (EQ-5D). [ Time Frame: Measured at baseline, 6 months and 12 months after randomization ] [ Designated as safety issue: No ]
    The standard EQ-5D questionnaire is completed by study participants.


Enrollment: 127
Study Start Date: August 2006
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392054

Locations
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
Canada
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
Germany
Abteilung Rhythmologie
Bad Krozingen, Germany, 79188
Asklepios Klinik St. Georg
Hamburg, Germany, 79188
University Hospital Eppendorf
Hamburg, Germany, D-20246
Italy
F. Miulli Hospital
Acquaviva delle Fonti, Bari, Italy, 70021
Sponsors and Collaborators
Population Health Research Institute
Johnson & Johnson
Investigators
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
  More Information

Additional Information:
Publications:
European Heart Rhythm Association; Heart Rhythm Society; Fuster V, Ryden 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. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Andrea Natale, unaffiliated IDE study sponsor, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT00392054     History of Changes
Other Study ID Numbers: USJan13/09CANAug1/06EUJan1/07
Study First Received: October 23, 2006
Last Updated: July 20, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
European Union: European Medicines Agency

Keywords provided by Population Health Research Institute:
Atrial Fibrillation
Paroxysmal
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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014