Status:
COMPLETED
INSIGHT (R)XT. Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT
Lead Sponsor:
Medtronic BRC
Conditions:
Atrial Fibrillation
Cardiac Arrhythmias
Eligibility:
All Genders
18+ years
Brief Summary
To describe the clinical indications for Reveal XT in diagnosis and continuous monitoring of arrhythmia and to explore the clinical applications and outcome of arrhythmia monitoring on patient care.
Detailed Description
Improving the diagnosis and management of cardiac rhythm disturbances remains a major challenge for physicians. Limitations of current cardiac arrhythmia monitoring using ECG, holters or event recorde...
Eligibility Criteria
Inclusion
- Patient implanted or scheduled for an implant with a Reveal XT Insertable Cardiac Monitor System for arrhythmia diagnosis or monitoring
- Patient must be willing to sign a Patient Data Release Form (or Informed Consent where applicable)
Exclusion
- Enrollment outside a 30-day window from the planned/performed Reveal XT implant procedure (from 15 days pre-implant until 15 days post implant)
- Patient is implanted with a pacemaker, ICD, CRT-device or an implantable hemodynamic monitoring system
- Unwillingness or inability to cooperate or give written informed consent or, if the patient is a minor and the legal guardian refuses to give consent
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
1003 Patients enrolled
Trial Details
Trial ID
NCT00680550
Start Date
April 1 2008
End Date
April 1 2013
Last Update
October 16 2013
Active Locations (56)
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1
Krankenhaus der Elisabethinen
Linz, Austria
2
Universitätsklinik für Innere Medizin
Vienna, Austria
3
Klinkum Wels-Grieskirchen GmbH
Wels, Austria
4
Republican Scientific Practical Center
Minsk, Belarus