NCT00984204

Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).

Detailed description

This is a prospective, multi-center, non-randomized study (historical data as control) for the evaluating the safety and efficacy of Therapy TM Cool PathTM Duo Ablation System for the treatment of typical atrial flutter (Cavo-triscupid isthmus dependent)

Conditions

• Typical Atrial Flutter

Interventions

Type	Name	Description
DEVICE	Therapy Cool Path Duo	All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-08-01
• Completion: 2012-01-01
• First posted: 2009-09-25
• Last updated: 2019-02-19
• Results posted: 2013-12-20

Locations

22 sites across 2 countries: United States, Canada