CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Reveal XT implantable loop recorderdevice
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/NCT01176617
NCT01176617N/ACompleted

Assessment of Arrhythmia Burden in Patients Undergoing Atrial Fibrillation Using an Implantable Loop Recorder (ILR) Versus Conventional Monitoring Strategy

University of Pennsylvania·interventional·Posted Aug 6, 2010·Updated Apr 5, 2018

In Brief

A clinical study evaluating Reveal XT implantable loop recorder for Atrial Fibrillation. Completed, enrolled 44 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if continuous monitoring using an implantable loop recorder (ie. a device that is placed just underneath the skin of the chest and monitors the heart rate and rhythm) for a year long period after atrial fibrillation ablation may be superior to the current conventional monitoring strategy used by us for determination of atrial fibrillation recurrence (ie. return of the abnormal heart rhythm) and/or arrythmia burden (ie. how long the abnormal rhythm continues or how often the rhythm occurs). Some data suggests that continuous monitoring over longer periods may be better in identifying recurrence of atrial fibrillation after ablation and thus assist in its overall management. The device being used for this study is the Reveal XT, which, is currently FDA approved for monitoring all varieties of cardiac rhythm disorders including atrial fibrillation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2010
Enrollment StartJun 1, 2012
Primary CompletionAug 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.9 years ago

Interventions

Reveal XT implantable loop recorderdevice

All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure.