Randomized Trial of Two Different Strategies to Treat Paroxysmal Atrial Fibrillation

NCT00293943 | Completed

• 1 other identifier: AFNET-B04-1
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 3

Brief 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

Atrial Fibrillation

Keywords

Atrial fibrillation; Pulmonary vein ablation; Linear lesions

Outcome Measures

Primary Outcomes (1)

• - 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

  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 Outcomes (8)

• - 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"

Interventions

Pulmonary vein ablation PROCEDURE

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atrial Fibrillation Network: lead
• C. R. Bard: collaborator
• Biosense Webster, Inc.: collaborator
• Abbott Medical Devices: collaborator
• Medtronic: collaborator

Study Sites (3)

General Hospital St. Georg, Department of Cardiology

Hamburg, 20099, Germany

Location

University Cardiac Center

Hamburg, 20246, Germany

Location

University Hospital, Department of Cardiology

Münster, 48149, Germany

Location

Related Publications (1)

• Kuck KH, Hoffmann BA, Ernst S, Wegscheider K, Treszl A, Metzner A, Eckardt L, Lewalter T, Breithardt G, Willems S; Gap-AF-AFNET 1 Investigators*. Impact of Complete Versus Incomplete Circumferential Lines Around the Pulmonary Veins During Catheter Ablation of Paroxysmal Atrial Fibrillation: Results From the Gap-Atrial Fibrillation-German Atrial Fibrillation Competence Network 1 Trial. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003337. doi: 10.1161/CIRCEP.115.003337.

  PMID: 26763226 DERIVED

Related Links

• Homepage of the German Atrial Fibrillation Network

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Günter Breithardt, MD

  Universität Münster

  PRINCIPAL INVESTIGATOR

• Karl-Heinz Kuck, MD

  General Hospital St. Georg, Hamburg

  PRINCIPAL INVESTIGATOR

• Stephan Willems, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2006
• First Posted: February 20, 2006
• Study Start: February 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 10, 2012

Record last verified: 2012-09

Locations

DE (3)