Study Stopped
Business reasons
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)
2 other identifiers
interventional
44
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2008
Shorter than P25 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 25, 2008
CompletedFirst Posted
Study publicly available on registry
August 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
October 26, 2012
CompletedOctober 26, 2012
September 1, 2012
1.3 years
August 25, 2008
August 27, 2012
September 26, 2012
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.
12 months
Number of Participants With Acute Procedural Success in Mesh Treated Patients.
During the mesh ablation procedure
Study Arms (2)
Mesh
EXPERIMENTALAblation with HD Mesh Ablation System
Drug
ACTIVE COMPARATORTreatment with anti-arrhythmic drugs
Interventions
5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation
Eligibility Criteria
You may qualify if:
- Patients with symptomatic paroxysmal atrial fibrillation who have failed at least one class I or III anti-arrhythmic drug
You may not qualify if:
- Previous surgical or catheter ablation to treat AF
- Permanent AF
- Uncontrolled or unstable medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- C. R. Bardlead
Study Sites (13)
University of California, San Diego Medical Center
San Diego, California, 92103, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012, United States
University of Florida
Gainesville, Florida, 32610, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Florida Heart Group
Orlando, Florida, 32803, United States
Bay Heart Group
Tampa, Florida, 33607, United States
Piedmont Hospital Research Institute
Atlanta, Georgia, 30309, United States
Northeast Cardiology Associates
Bangor, Maine, 04401, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
St. John's Medical Research Institute
Springfield, Missouri, 65807, United States
Lehigh Valley Heart Specialists
Allentown, Pennsylvania, 18103, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to the study's early termination and enrollment of only 7 randomized patients, predefined study endpoints were not evaluable. Treated patients were followed through 12 months postprocedure and data were summarized where possible.
Results Point of Contact
- Title
- Anne Marie Harcarik
- Organization
- CR Bard
Study Officials
- STUDY DIRECTOR
Anne Marie Harcarik
C. R. Bard, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2008
First Posted
August 26, 2008
Study Start
July 1, 2008
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
October 26, 2012
Results First Posted
October 26, 2012
Record last verified: 2012-09