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

NCT00741611 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-10-26

Study results available
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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.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

HD Mesh Ablation System

Ablation using the HD Mesh Ablation System

DRUG

Anti-arrhythmic drugs

5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Anne Marie Harcarik · C. R. Bard, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00741611 on ClinicalTrials.gov