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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
HD Mesh Ablation System
Anti-arrhythmic drugs
Sponsored by
C. R. Bard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Diego Medical Center
  • Aurora Denver Cardiology Associates
  • University of Florida
  • Mayo Clinic
  • Florida Heart Group
  • Bay Heart Group
  • Piedmont Hospital Research Institute
  • Northeast Cardiology Associates
  • Massachusetts General Hospital
  • Caritas St. Elizabeth's Medical Center
  • St. John's Medical Research Institute
  • Lehigh Valley Heart Specialists
  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mesh

Drug

Arm Description

Ablation with HD Mesh Ablation System

Treatment with anti-arrhythmic drugs

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
August 25, 2008
Last Updated
September 26, 2012
Sponsor
C. R. Bard
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1. Study Identification

Unique Protocol Identification Number
NCT00741611
Brief Title
Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation
Acronym
MAGELLAN
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
Business reasons
Study Start Date
July 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesh
Arm Type
Experimental
Arm Description
Ablation with HD Mesh Ablation System
Arm Title
Drug
Arm Type
Active Comparator
Arm Description
Treatment with anti-arrhythmic drugs
Intervention Type
Device
Intervention Name(s)
HD Mesh Ablation System
Intervention Description
Ablation using the HD Mesh Ablation System
Intervention Type
Drug
Intervention Name(s)
Anti-arrhythmic drugs
Intervention Description
5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation
Primary Outcome Measure Information:
Title
Number of Participants With Major Complications
Description
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.
Time Frame
12 months
Title
Number of Participants With Serious Atrial Fibrillation Events
Description
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.
Time Frame
12 months
Title
Number of Participants With Freedom From Symptomatic Atrial Fibrillation
Description
Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.
Description
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.
Time Frame
12 months
Title
Number of Participants With Acute Procedural Success in Mesh Treated Patients.
Description
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
Time Frame
During the mesh ablation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Marie Harcarik
Organizational Affiliation
C. R. Bard, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of California, San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Aurora Denver Cardiology Associates
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Florida Heart Group
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Bay Heart Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Piedmont Hospital Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Northeast Cardiology Associates
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Caritas St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
St. John's Medical Research Institute
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Lehigh Valley Heart Specialists
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation

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