Randomized Trial of Two Different Strategies to Treat Paroxysmal Atrial Fibrillation

This study has been completed.
Sponsor:
Collaborators:
C. R. Bard
Biosense Webster, Inc.
St. Jude Medical
Medtronic
Information provided by (Responsible Party):
German Atrial Fibrillation Network
ClinicalTrials.gov Identifier:
NCT00293943
First received: February 17, 2006
Last updated: September 7, 2012
Last verified: September 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial to Investigate the Significance of Complete Versus Incomplete Electrical Isolation of Pulmonary Veins by Radiofrequency-induced Linear Lesions

Resource links provided by NLM:


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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    - Time to first occurrence of any documented relapse of atrial fibrillation

  • - Number and total duration of documented AF episodes [ Designated as safety issue: No ]
    - Number and total duration of documented AF episodes

  • - Number of hospitalizations due to atrial fibrillation [ Designated as safety issue: No ]
    - Number of hospitalizations due to atrial fibrillation

  • - Number of visits without hospitalization [ Designated as safety issue: No ]
    - Number of visits without hospitalization

  • - Number of "serious adverse events of special interest" [ Designated as safety issue: No ]
    - Number of "serious adverse events of special interest"

  • - Procedure parameters (duration, fluoroscopy, number of radiofrequency applications) [ Designated as safety issue: No ]
    - Procedure parameters (duration, fluoroscopy, number of radiofrequency applications)

  • - Procedural costs (including the costs of re-ablation if AF recurrence occurs) [ Designated as safety issue: No ]
    - Procedural costs (including the costs of re-ablation if AF recurrence occurs)

  • - Quality of life [ Designated as safety issue: No ]
    - Quality of life


Enrollment: 232
Study Start Date: February 2006
Study Completion Date: August 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293943

Locations
Germany
University Cardiac Center
Hamburg, Germany, 20246
General Hospital St. Georg, Department of Cardiology
Hamburg, Germany, 20099
University Hospital, Department of Cardiology
Münster, Germany, 48149
Sponsors and Collaborators
German Atrial Fibrillation Network
C. R. 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

Additional Information:
No publications provided

Responsible Party: German Atrial Fibrillation Network
ClinicalTrials.gov Identifier: NCT00293943     History of Changes
Other Study ID Numbers: AFNET-B04-1
Study First Received: February 17, 2006
Last Updated: September 7, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 16, 2014