Clinical trial NCT00741611: Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Major Complications
timeFrame: 12 months
measure: Number of Participants With Serious Atrial Fibrillation Events
timeFrame: 12 months
measure: Number of Participants With Freedom From Symptomatic Atrial Fibrillation
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.
timeFrame: 12 months
measure: Number of Participants With Acute Procedural Success in Mesh Treated Patients.
timeFrame: During the mesh ablation procedure
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego Medical Center
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Orlando
country: United States
facility: Florida Heart Group
state: Florida
city: Tampa
country: United States
facility: Bay Heart Group
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital Research Institute
state: Georgia
city: Bangor
country: United States
facility: Northeast Cardiology Associates
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: St. John's Medical Research Institute
state: Missouri
city: Allentown
country: United States
facility: Lehigh Valley Heart Specialists
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: C. R. Bard, Inc.
name: Anne Marie Harcarik
role: STUDY_DIRECTOR
References: