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

Phase 3

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Mesh	HD Mesh Ablation System	Ablation with HD Mesh Ablation System
Drug	Anti-arrhythmic drugs	Treatment with anti-arrhythmic drugs

Primary Outcome Measures

Name	Time	Method
Number of Participants With Major Complications	12 months	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	12 months	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	12 months	Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.	12 months	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.	During the mesh ablation procedure	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

Locations (13): Piedmont Hospital Research Institute
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Atlanta, Georgia, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
Caritas St. Elizabeth's Medical Center
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Boston, Massachusetts, United States
St. John's Medical Research Institute
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Springfield, Missouri, United States
Lehigh Valley Heart Specialists
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Allentown, Pennsylvania, United States
Aurora Denver Cardiology Associates
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Aurora, Colorado, United States
Bay Heart Group
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Tampa, Florida, United States
University of California, San Diego Medical Center
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San Diego, California, United States
University of Florida
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Gainesville, Florida, United States
Florida Heart Group
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Orlando, Florida, United States
Mayo Clinic
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Jacksonville, Florida, United States
Northeast Cardiology Associates
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Bangor, Maine, United States
Rhode Island Hospital
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Providence, Rhode Island, United States