NCT01408485

Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Typical Atrial Flutter

Interventions

Type	Name	Description
DEVICE	Therapy™ Cool Flex™ Irrigated Ablation System	The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of: * Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter * IBI 1500T9 V1.43 RF Generator

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-06-01
• Completion: 2012-10-01
• First posted: 2011-08-03
• Last updated: 2019-02-15
• Results posted: 2014-06-23

Locations

24 sites across 2 countries: United States, Canada