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Clinical Trial 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).


Clinical Trial 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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00984204
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase Phase 3
Start date October 2009
Completion date January 2012

See also
  Status Clinical Trial Phase
Withdrawn NCT04434599 - Fluoroscopic, Contact Force and Local Impedance With Ultra-high Density Mapping Guided Radiofrequency Ablation Comparison for cavoTricuspid Isthmus dependenT Atrial fluttER: the FLUTTER Study N/A
Recruiting NCT05777850 - High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter N/A
Completed NCT01401361 - Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System Phase 3
Withdrawn NCT01710150 - Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter N/A
Completed NCT01408485 - Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter N/A
Completed NCT04658940 - AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter) N/A
Recruiting NCT00750711 - Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters N/A
Recruiting NCT03867266 - Typical Atrial Flutter, Ablation Index and Point by Point Ablation
Not yet recruiting NCT06157437 - An Exploratory Study of Focal Pulse Ablation System in the Treatment of Typical Atrial Flutter N/A
Recruiting NCT04657055 - AcQBlate Force Sensing Ablation System EU Study for Atrial Flutter (AcQForce Flutter-EU) N/A