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

NCT ID: NCT00392054

Last Updated: 2020-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2012-02-29

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.

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Catheter Ablation

Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation

Group Type: EXPERIMENTAL

Pulmonary Vein Isolation performed by Catheter Ablation

Intervention Type: PROCEDURE

Ablation will be done to achieve entrance block into all pulmonary veins.

Antiarrhythmic Drug Therapy

Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation

Group Type: ACTIVE_COMPARATOR

Conventional Antiarrhythmic Drug Therapy

Intervention Type: DRUG

Anti-Arrhythmic Drugs per ACC/AHA 2006 Guidelines for the Management of Patients with AF

Interventions

Pulmonary Vein Isolation performed by Catheter Ablation

Ablation will be done to achieve entrance block into all pulmonary veins.

Intervention Type: PROCEDURE

Conventional Antiarrhythmic Drug Therapy

Anti-Arrhythmic Drugs per ACC/AHA 2006 Guidelines for the Management of Patients with AF

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos A Morillo, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute, Hamilton Health Sciences Corporation and McMaster University

Natale Andrea, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia Research Foundation

Locations

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

Countries

United States; Canada; Czechia; Germany; Italy

References

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Related Links

http://www.phri.ca

Population Health Research Institute - The RAAFT Study - Sponsor and Central Coordination

Other Identifiers

USJan13/09CANAug1/06EUJan1/07

Identifier Type: -

Identifier Source: org_study_id