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A Randomized Controlled Trial of Radiofrequency Ablation for the Treatment of Paroxysmal Atrial Fibrillation Using the Bard High Density Mesh Ablation System (MAGELLAN)

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Trial Conditions
  • Paroxysmal Atrial Fibrillation
What is the purpose of this trial?

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.

Date & Status

Terminated

Who can Participate?

Eligibility

Ages:
21  - 75 

Gender:
Both

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:

- Previous surgical or catheter ablation to treat AF

- Permanent AF

- Uncontrolled or unstable medical conditions

- Other exclusion criteria

Gender: Both
Steward Physician(s)
  • Anne Marie Harcarik
Facilities
  • St. Elizabeth's Medical Center - Terminated
Trial Interventions
Device
  • HD Mesh Ablation System
Drug
  • Anti-arrhythmic drugs
Physician Researcher

Investigator Name:

  • Anne Marie Harcarik

Other Information

Sponsor: C. R. Bard
Phase: Phase 3
Trial ID: NCT00741611
Volunteers:  Not Accepting Healthy Volunteers

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