Status:
COMPLETED
Reveal® XT Performance Trial (XPECT)
Lead Sponsor:
Medtronic BRC
Conditions:
Atrial Fibrillation
Risk of Cardiac Arrhythmias
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to quantify the accuracy of the atrial fibrillation diagnostics of the Reveal® XT in a clinical setting and to verify overall system performance, R-wave sensing performanc...
Detailed Description
The study is a prospective, non-randomized, multi-center international post-market study. The study will be conducted at 20-30 centers primarily in Europe. The study will be conducted at least in Ger...
Eligibility Criteria
Inclusion
- Patient is willing and able to provide his/her informed consent
- Patient has been implanted with a Reveal® XT
- Patient fulfills at least one of the following three additional requirements
- is scheduled for PV ablation or surgical rhythm control intervention, and the PV ablation or surgical intervention can be deferred until study completion or
- has documented frequent AF or frequent symptoms attributable to AF or
- has undergone PV ablation within the last 6 months and still has symptoms attributable to AF
Exclusion
- Patient has an implanted pacemaker or ICD
- Patient has persistent or permanent AF
- Patient is allergic to adhesive ECG electrodes
- The study will interfere with a therapeutic or diagnostic procedure which is planned or expected during the study period
- Patient is participating in another study that is expected to compromise the results of this study
- Patient is a minor, legally incompetent, or does not meet other local requirements for participation in a clinical study
- Patient is pregnant
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT00680927
Start Date
September 1 2007
End Date
August 1 2008
Last Update
June 3 2015
Active Locations (24)
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1
LKH - Universitätskliniken
Innsbruck, Austria, A-6020
2
A.ö. Krankenhaus der Elisabethinen Linz
Linz, Austria, 4010
3
Salzburger Landeskliniken
Salzburg, Austria, A-5020
4
University Gasthuisberg
Leuven, Belgium, B-3000