CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 188 enrolled
Drug / intervention
Therapy Cool Path Duodevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00984204
NCT00984204Phase 3Completed
CompareCT.gov

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

Abbott Medical Devices·interventional·Posted Sep 25, 2009·Updated Feb 19, 2019

In Brief

A Phase 3 clinical trial evaluating Therapy Cool Path Duo for Typical Atrial Flutter. Completed, enrolled 188 participants across 22 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTypical Atrial Flutter
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 25, 2009
Enrollment StartOct 1, 2009
Primary CompletionAug 1, 2010
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.8 years ago

Interventions

Therapy Cool Path Duodevice

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