NAVISTAR® THERMOCOOL® Catheter Post Approval Registry

Status Completed

Clinical Trial Summary

The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).

Clinical Trial Description

This registry is a prospective, multi-center, non-randomized post approval evaluation comprised of two (2) registry arms with independent hypotheses. The registry arms are defined as; Arm 1) physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year and Arm 2) physicians who perform less than 50 atrial fibrillation ablation procedures per year. Subjects with drug refractory recurrent symptomatic PAF will be considered for this post approval registry. This registry will be conducted at up to 40 centers in a minimum of 381 evaluable subjects. The devices are currently FDA approved for commercial distribution under PMA #P030031/S11. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00964392
Study type	Interventional
Source	Biosense Webster, Inc.
Contact
Status	Completed
Phase	Phase 4
Start date	September 1, 2009
Completion date	January 5, 2018

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See also
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NAVISTAR® THERMOCOOL® Catheter Post Approval Registry — AF Registry

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms