CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 70 enrolled
Drug / intervention
Atrial flutter irrigated catheter +1 moredevice
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/NCT02088489
NCT02088489Phase 3Completed
CompareCT.gov

Effectiveness and Safety of Porous Tip Irrigated Ablation Catheter Versus Conventional Irrigated Catheter in Isthmus Dependent Atrial Flutter Ablation: a Randomized Study

Hospital Clinic of Barcelona·interventional·Posted Mar 17, 2014·Updated Aug 10, 2017

In Brief

A Phase 3 clinical trial evaluating Atrial flutter irrigated catheter and Atrial flutter porous tip catheter for Atrial Flutter. Completed, enrolled 70 participants across 1 site.

Detailed Summary

Porous tip catheter use reduces procedure time and RF time in atrial flutter ablation with the same safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Flutter
CountriesSpain
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 17, 2014
Enrollment StartNov 1, 2012
Primary CompletionFeb 1, 2015
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.3 years ago

Interventions

Atrial flutter irrigated catheterdevice

A duodecapolar isthmic curve catheter will be introduced to demonstrate cavo-tricuspidal bidirectional block. We performed atrial flutter ablation with conventional irrigated Thermocool® (Biosense Webster, Diamond Bar, CA) catheter Continuous lesions from tricuspidal annulus to inferior vena cava will be realized and then complete isthmic block will be confirmed by bidirectional stimulation

Atrial flutter porous tip catheterdevice

A duodecapolar isthmic curve catheter will be introduced to demonstrate cavo-tricuspidal bidirectional block. We performed atrial flutter ablation with Porous tip Thermocool® SF(Biosense Webster, Diamond Bar, CA)irrigated catheter Continuous lesions from tricuspidal annulus to inferior vena cava will be realized and then complete isthmic block will be confirmed by bidirectional stimulation