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Randomized Trial of Two Different Strategies to Treat Paroxysmal Atrial Fibrillation

NCT00293943 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2012-09-10

No results posted yet for this study

Summary

The purpose of this study is to investigate the significance of complete versus incomplete electrical isolation of pulmonary veins by radiofrequency-induced linear lesions in patients with paroxysmal atrial fibrillation.

The study hypothesis ist that the complete linear PV isolation ablation is superior to the non-complete linear PV isolation on the outcome of patients with idiopathic drug-refractory atrial fibrillation. As a second hypothesis in this adaptive study design, the non-inferiority of the complete linear PV isolation strategy will be tested.

Conditions

Interventions

PROCEDURE

Pulmonary vein ablation

Sponsors & Collaborators

  • C. R. Bard

    collaborator INDUSTRY

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Medtronic

    collaborator INDUSTRY

  • Atrial Fibrillation Network

    lead OTHER

Principal Investigators

  • Günter Breithardt, MD · Universität Münster

  • Karl-Heinz Kuck, MD · General Hospital St. Georg, Hamburg

  • Stephan Willems, MD · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2010-03-31
Completion
2010-08-31

Countries

  • Germany

Study Locations

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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 NCT00293943 on ClinicalTrials.gov