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Randomized Trial of Two Different Strategies to Treat Paroxysmal Atrial Fibrillation
This study is currently recruiting participants.
Verified by German Atrial Fibrillation Network, February 2006
Sponsors and Collaborators: German Atrial Fibrillation Network
Bard
Biosense Webster, Inc.
St. Jude Medical
Medtronic
Information provided by: German Atrial Fibrillation Network
ClinicalTrials.gov Identifier: NCT00293943
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Procedure: Pulmonary vein ablation

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Randomized Trial to Investigate the Significance of Complete Versus Incomplete Electrical Isolation of Pulmonary Veins by Radiofrequency-Induced Linear Lesions

Further study details as provided by German Atrial Fibrillation Network:

Primary Outcome Measures:
  • - Time to first recurrence of symptomatic AF with duration of more than 30 sec on trans-telephonic ECG monitoring or detection of asymptomatic AF defined as 2 consecutive recordings of AF during a minimum of 72 hours

Secondary Outcome Measures:
  • - Time to first occurrence of any documented relapse of atrial fibrillation
  • - Number and total duration of documented AF episodes
  • - Number of hospitalizations due to atrial fibrillation
  • - Number of visits without hospitalization
  • - Number of “serious adverse events of special interest”
  • - Procedure parameters (duration, fluoroscopy, number of radiofrequency applications)
  • - Procedural costs (including the costs of re-ablation if AF recurrence occurs)
  • - Quality of life

Estimated Enrollment: 192
Study Start Date: February 2006
Estimated Study Completion Date: August 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic paroxysmal symptomatic atrial fibrillation refractory to antiarrhythmic therapy
  • Age 50 – 85 years
  • Patient willing to participate in randomized trial and an invasive follow-up at month 3 (-6)
  • Structural normal heart
  • Patient willing and able to participate in 12 months follow-up period
  • ECG documentation of atrial fibrillation (ECG, Holter, event recorders, etc) for at least one AF event in the prior year (related to symptomatic or asymptomatic episodes) with an average number of one episode per month
  • Written informed consent of the patient

Exclusion Criteria:

  • Patients who have had previous pulmonary vein ablation procedures Patients with atrial fibrillation secondary to a reversible cause
  • Known presence of intracardiac or other thrombi
  • Evidence of obstructive lung disease requiring bronchodilator therapy
  • Pregnant females or those of child bearing potential who have not had a negative pregnancy test within 48 hours before treatment.
  • Other medical illness (i.e. cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than one year)
  • History of bleeding diathesis or suspected pro-coagulant state contraindication to anticoagulation therapy
  • Hyperthyroidism or hypothyroidism manifested clinically and in laboratory tests (TSH, T3, T4)
  • Participation in a clinical trial within the last 30 days. Simultaneous participation in a registry (e.g. project AB1 of the AFNET) is permitted.
  • Drug addiction or chronic alcohol abuse
  • Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical trial
  • Evidence of an uncooperative attitude
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293943

Contacts
Contact: Stephan Willems, MD +49-(0)40-42803 ext 4120 willems@uke.uni-hamburg.de
Contact: Sabine Ernst, MD +49-(0)40-181885 ext 2305 SErnst1708@aol.com

Locations
Germany
University Cardiac Center Recruiting
Hamburg, Germany, 20246
Contact: Stephan Willems, MD     +49-(0)40-42803 ext 4120     willems@uke.uni-hamburg.de    
Contact: Boris A Lutomsky, MD     +49-(0)40-42803 ext 4733     lutomsky@uke.uni-hamburg.de    
General Hospital St. Georg, Department of Cardiology Recruiting
Hamburg, Germany, 20099
Contact: Karl H Kuck, MD     +49-(0)40-181885 ext 2305     Karl_Heinz.Kuck@ak-stgeorg.lbk-hh.de    
Contact: Sabine Ernst, MD     +49-(0)40-181885 ext 2305     SErnst1708@aol.com    
University Hospital, Department of Cardiology Recruiting
MÜNSTER, Germany, 48149
Contact: Günter Breithardt, MD     +49-(0)251-834 ext 7617     g.breithardt@uni-muenster.de    
Contact: Lars Eckhardt, MD     +49-(0)251-834 ext 7687     l.eckardt@uni-muenster.de    
Sponsors and Collaborators
German Atrial Fibrillation Network
Bard
Biosense Webster, Inc.
St. Jude Medical
Medtronic
Investigators
Principal Investigator: Günter Breithardt, MD University of Münster
Principal Investigator: Karl-Heinz Kuck, MD General Hospital St. Georg, Hamburg
Principal Investigator: Stephan Willems, MD Universitätsklinikum Hamburg-Eppendorf
  More Information

Homepage of the German Atrial Fibrillation Network  This link exits the ClinicalTrials.gov site

Study ID Numbers: AFNET-B04-1
Study First Received: February 17, 2006
Last Updated: February 17, 2006
ClinicalTrials.gov Identifier: NCT00293943  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Atrial Fibrillation Network:
Atrial fibrillation
Pulmonary vein ablation
Linear lesions

Study placed in the following topic categories:
Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009