CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 324 enrolled
Drug / intervention
SJM Irrigated Cardiac Ablation System +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/NCT01056328
NCT01056328N/ACompleted
CompareCT.gov

Irrigated Ablation System Evaluation for AF

Abbott Medical Devices·interventional·Posted Jan 26, 2010·Updated Feb 26, 2019

In Brief

A clinical study evaluating SJM Irrigated Cardiac Ablation System and FDA approved Open Irrigated RF Ablation System for Paroxysmal Atrial Fibrillation. Completed, enrolled 324 participants across 30 sites in 3 countries.

Detailed Summary

The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Atrial Fibrillation
CountriesCanada, South Korea, United States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 26, 2010
Enrollment StartFeb 1, 2010
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 16.4 years ago

Interventions

SJM Irrigated Cardiac Ablation Systemdevice

Irrigated ablation catheter

FDA approved Open Irrigated RF Ablation Systemdevice

Irrigated ablation catheter