Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation - Full Text View

Sponsored by:	C. R. Bard
Information provided by:	C. R. Bard
ClinicalTrials.gov Identifier:	NCT00741611

Purpose

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.

Condition	Intervention	Phase
Paroxysmal Atrial Fibrillation	Device: HD Mesh Ablation System Drug: Anti-arrhythmic drugs	Phase III

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
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)

Further study details as provided by C. R. Bard:

Primary Outcome Measures:

Major Complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Serious AF Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Freedom from symptomatic AF [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of PV stenosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Acute procedural success [ Time Frame: Acute ] [ Designated as safety issue: No ]

Estimated Enrollment:	369
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Mesh: Experimental Ablation with HD Mesh Ablation System	Device: HD Mesh Ablation System Ablation using the HD Mesh Ablation System
Drug: Active Comparator Treatment with anti-arrhythmic drugs	Drug: Anti-arrhythmic drugs 5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741611

Contacts

Contact: Kevin Anderson

800-824-8724

kevin.anderson@crbard.com

Locations

United States, Colorado
Andrew Cohen, M.D.	Recruiting
Aurora, Colorado, United States, 80012

Sponsors and Collaborators

C. R. Bard

Investigators

Study Director:

Carol A Loring, RN

Bard Electrophysiology, division of C. R. Bard, Inc.

More Information

Responsible Party:	Bard Electrophysiology, division of C. R. Bard, Inc. ( Carol A. Loring, R.N., Director of Clinical Affairs )
Study ID Numbers:	BEP-4408-2007, IDE # G070179
Study First Received:	August 25, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00741611
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009