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

A Randomized Controlled Trial of Radiofrequency Ablation for the Treatment of Paroxysmal Atrial Fibrillation Using the Bard High Density Mesh Ablation System (MAGELLAN)

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.

Study Overview

• Status: Terminated
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: HD Mesh Ablation System; Drug: Anti-arrhythmic drugs

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Major Complications	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.	12 months
Number of Participants With Serious Atrial Fibrillation Events	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.	12 months
Number of Participants With Freedom From Symptomatic Atrial Fibrillation	Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.	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.	12 months
Number of Participants With Acute Procedural Success in Mesh Treated Patients.	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	During the mesh ablation procedure

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Study Director: Anne Marie Harcarik, C. R. Bard, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: August 25, 2008
• First Submitted That Met QC Criteria: August 25, 2008
• First Posted (Estimate): August 26, 2008

Study Record Updates

• Last Update Posted (Estimate): October 26, 2012
• Last Update Submitted That Met QC Criteria: September 26, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Anti-Arrhythmia Agents
• Other Study ID Numbers: BEP-4408-2007; IDE # G070179