CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 79 enrolled
Drug / intervention
Intracardiac echocardiographydevice
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/NCT02426710
NCT02426710Phase 3Completed

The Usefulness of Intracardiac Echocardiography in Atrial Flutter Ablation - a Randomized Study

Charles University, Czech Republic·interventional·Posted Apr 27, 2015·Updated Jan 31, 2019

In Brief

A Phase 3 clinical trial evaluating Intracardiac echocardiography for ATRIAL FLUTTER. Completed, enrolled 79 participants across 1 site.

Detailed Summary

Background: Radiofrequency ablation of typical atrial flutter present the most effective treament option in treatment of atrial flutter. Despite its high efficacy, due tovariant anatomy of cavotricuspid isthmus (CTI), i.e. location of right coronary artery, pouches, the achievment of complete bidirectional block across the CTI is sometimes chalenging. Intracardiac echocardiography (ICE) is a very usefull tool for on-line vizualization of the anatomy of the atria and also for the location of catheter position on CTI during ablation. If the routine use of ICE is associated with easier atrial fluter ablation is not clear. Methods: One hundred consecutive patients indicated for typical atrial flutter ablation will be enrolled into the study. The patients will be randomized into group (A) ablation with use of ICE and (B) ablation without ICE. The ablation will be done in both groups by two diagnostic catheters (10-pole positioned in coronary sinus and 20-pole halo catheter positioned in the right atrium) and radiofrequency ablation catheter. The end-point of the ablation is the achievment of the bicidrectional block across the CTI. The end-points of the study are 1) the total length of the procedure, 2) the fluoroscopy time and 3) the ablation time. The safety end-point is clinically significant bleeding from the groin due to additional puncture for ICE catheter. Discussion: We hypothesize the use of ICE wil shorten the radiofrequency energy delivery, fluoroscopy time and the length of the procedure without increasing the bleeding.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsATRIAL FLUTTER
CountriesCzechia
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 27, 2015
Enrollment StartJun 1, 2014
Primary CompletionApr 10, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.2 years ago

Interventions

Intracardiac echocardiographydevice

Flutter ablation will be done using intracardiac echocardiography.