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

This study has been terminated.
(Business reasons)
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00741611
First received: August 25, 2008
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Paroxysmal Atrial Fibrillation
 Device: HD Mesh Ablation System
Drug: Anti-arrhythmic drugs
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Number of Participants With Major Complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Serious Atrial Fibrillation Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Freedom From Symptomatic Atrial Fibrillation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.


Secondary Outcome Measures:
  • Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Acute Procedural Success in Mesh Treated Patients. [ Time Frame: During the mesh ablation procedure ] [ Designated as safety issue: No ]
    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


Enrollment: 44
Study Start Date: July 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741611

Locations
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
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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
Investigators
Study Director: Anne Marie Harcarik C. R. Bard, Inc.
  More Information

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00741611     History of Changes
Other Study ID Numbers: BEP-4408-2007, IDE # G070179
Study First Received: August 25, 2008
Results First Received: August 27, 2012
Last Updated: September 26, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013