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

Stopped early · Phase 3

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT00741611

Run by

C. R. Bard

People needed

44

Starts

2008-07-01

Expected to finish

2009-11-01

Last updated by the study team

2012-10-26

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with symptomatic paroxysmal atrial fibrillation who have failed at least one class I or III anti-arrhythmic drug
• Other inclusion criteria

You may not qualify if…

• Previous surgical or catheter ablation to treat AF
• Permanent AF
• Uncontrolled or unstable medical conditions
• Other exclusion criteria

Where it is running

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

Full record on ClinicalTrials.gov

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