Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation (MAGELLAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00741611
Recruitment Status : Terminated (Business reasons)
First Posted : August 26, 2008
Results First Posted : October 26, 2012
Last Update Posted : October 26, 2012
Information provided by (Responsible Party):
C. R. Bard

Brief Summary:
This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh Ablation System is as safe as and more effective than anti-arrhythmic drugs.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: HD Mesh Ablation System Drug: Anti-arrhythmic drugs Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Radiofrequency Ablation for the Treatment of Paroxysmal Atrial Fibrillation Using the Bard High Density Mesh Ablation System (MAGELLAN)
Study Start Date : July 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mesh
Ablation with HD Mesh Ablation System
Device: HD Mesh Ablation System
Ablation using the HD Mesh Ablation System
Active Comparator: Drug
Treatment with anti-arrhythmic drugs
Drug: Anti-arrhythmic drugs
5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation

Primary Outcome Measures :
  1. Number of Participants With Major Complications [ Time Frame: 12 months ]
    A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure.

  2. Number of Participants With Serious Atrial Fibrillation Events [ Time Frame: 12 months ]
    Due to the early study termination and the small number of randomized patients (seven), this primary endpoint analysis (comparison of the rate of events in the mesh group to the rate in the drug group) could not be performed. Counts of events occurring in the 36 treated patients are reported by study group instead.

  3. Number of Participants With Freedom From Symptomatic Atrial Fibrillation [ Time Frame: 12 months ]
    Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.

Secondary Outcome Measures :
  1. Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients. [ Time Frame: 12 months ]
    Defined as a greater than or equal to 70% diameter reduction in a pulmonary vein compared with the baseline measurement as assessed by an independent core imaging laboratory.

  2. Number of Participants With Acute Procedural Success in Mesh Treated Patients. [ Time Frame: During the mesh ablation procedure ]
    Acute procedural success was defined as the ability to isolate 3 of 4 pulmonary veins with the mesh ablation system alone without the need for further ablation with a distal tip catheter

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with symptomatic paroxysmal atrial fibrillation who have failed at least one class I or III anti-arrhythmic drug
  • Other inclusion criteria

Exclusion Criteria:

  • Previous surgical or catheter ablation to treat AF
  • Permanent AF
  • Uncontrolled or unstable medical conditions
  • Other exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00741611

United States, California
University of California, San Diego Medical Center
San Diego, California, United States, 92103
United States, Colorado
Aurora Denver Cardiology Associates
Aurora, Colorado, United States, 80012
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Mayo Clinic
Jacksonville, Florida, United States, 32224
Florida Heart Group
Orlando, Florida, United States, 32803
Bay Heart Group
Tampa, Florida, United States, 33607
United States, Georgia
Piedmont Hospital Research Institute
Atlanta, Georgia, United States, 30309
United States, Maine
Northeast Cardiology Associates
Bangor, Maine, United States, 04401
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
United States, Missouri
St. John's Medical Research Institute
Springfield, Missouri, United States, 65807
United States, Pennsylvania
Lehigh Valley Heart Specialists
Allentown, Pennsylvania, United States, 18103
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
C. R. Bard
Study Director: Anne Marie Harcarik C. R. Bard, Inc.

Responsible Party: C. R. Bard Identifier: NCT00741611     History of Changes
Other Study ID Numbers: BEP-4408-2007
IDE # G070179
First Posted: August 26, 2008    Key Record Dates
Results First Posted: October 26, 2012
Last Update Posted: October 26, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents