CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
Treatment Armdevice
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/NCT01401361
NCT01401361Phase 3Completed
CompareCT.gov

Clinical Evaluation of Contact™ Therapy™ Cool Path™ Cardiac Ablation System in Conjunction With EnSite Velocity Contact™ Technology for the Treatment of Typical Atrial Flutter

Abbott Medical Devices·interventional·Posted Jul 25, 2011·Updated Feb 15, 2019

In Brief

A Phase 3 clinical trial evaluating Treatment Arm for Typical Atrial Flutter. Completed, enrolled 150 participants across 20 sites in 2 countries.

Detailed Summary

To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter * Does not result into unacceptable risk of intra-procedural composite serious adverse events and, * Does not affect efficacy of the ablation procedure The study will also evaluate the

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 25, 2011
Enrollment StartOct 1, 2011
Primary CompletionApr 1, 2012
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.9 years ago

Interventions

Treatment Armdevice

The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .