At a glance
ClinicalIndex Comparison RecordN/ACompleted· 200 enrolled
Drug / intervention
Therapy™ Cool Flex™ Irrigated Ablation Systemdevice
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.
Clinical Evaluation of Therapy™ Cool Flex™ Irrigated Ablation System for the Treatment of Typical Atrial Flutter
In Brief
A clinical study evaluating Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter. Completed, enrolled 200 participants across 24 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTypical Atrial Flutter
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartNov 2011
Primary CompletionJun 2012
Study CompletionOct 2012
TodayJul 2026
First PostedAug 3, 2011
Enrollment StartNov 1, 2011
Primary CompletionJun 1, 2012
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.9 years ago
Interventions
Therapy™ Cool Flex™ Irrigated Ablation Systemdevice
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