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Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter — FLEXION-AFL  

Typical Atrial Flutter Clinical Trial

Official title:
Clinical Evaluation of Therapy™ Cool Flex™ Irrigated Ablation System for the Treatment of Typical Atrial Flutter

Clinical Trial Summary

To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.

Clinical Trial Description

This will be a prospective, multi-center and non-randomized study. All treated patients will receive ablation therapy for typical atrial flutter using the TherapyTM Cool FlexTM Irrigated Ablation System. Historical data from combined published (PMA P060019 Cool Path) and reported (IDE G090109 Cool Path Duo) Atrial Flutter studies will be used to determine performance goals for study endpoints. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01408485
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase N/A
Start date November 2011
Completion date October 2012
View Details
See also
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