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

NCT00392054 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2020-01-31

Study results available
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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.

Conditions

Interventions

PROCEDURE

Pulmonary Vein Isolation performed by Catheter Ablation

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

DRUG

Conventional Antiarrhythmic Drug Therapy

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

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Carlos A Morillo, MD · Population Health Research Institute, Hamilton Health Sciences Corporation and McMaster University

  • Natale Andrea, MD · Texas Cardiac Arrhythmia Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00392054 on ClinicalTrials.gov