INSIGHT (R)XT. Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT

Tracking Information

Start Date  ICMJEApril 2008
Estimated Primary Completion DateSeptember 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
Original Primary Outcome Measures  ICMJE 
Change HistoryComplete list of historical versions of study NCT00680550 on Archive Site

Descriptive Information

Brief Title  ICMJEINSIGHT (R)XT. Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT
Official Title  ICMJEIndications for Diagnosis, Arrhythmia and Monitoring of Reveal XT.
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 recorders are that these methods are non-continuous and/or automatic arrhythmia detection is often impossible. The Medtronic Reveal XT Insertable Cardiac Monitor is a programmable device which continuously monitors the patient's subcutaneous ECG and provides information regarding arrhythmia episodes, long term trending of AF burden, patient's activity and heart rate variability. The Reveal XT records cardiac information in response to patient activation and automatically detected arrhythmias thereby offering advantages over conventional tools for long-term arrhythmia monitoring with regard to compliance and recording time.

The clinical applications for Reveal XT are varied. Diagnostic, arrhythmia monitoring and arrhythmia management functions can be discriminated.

This study is a prospective, observational, multicenter international post-market study. The results of this study will describe the different patient groups for which the Reveal XT is being used for the diagnosis and monitoring of various cardiac arrhythmias. This study will also collect data regarding the clinical consequences of using the Reveal XT and the influence of Reveal XT data on clinical care pathways. The physician as well as the patient's satisfaction with the device will be evaluated. The study will be conducted in 80-100 centers primarily in Europe. It is expected that 500 patients will be enrolled.

Study Phase 
Study Type  ICMJEObservational
Study Design  ICMJEOther, Prospective
Condition  ICMJE
  • Atrial Fibrillation
  • Risk of Cardiac Arrhythmias

Recruitment Information

Estimated Enrollment  ICMJE500
Estimated Completion DateSeptember 2011
Estimated Primary Completion DateSeptember 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Despina Voulgaraki, PhD+31 (0)43 356
Contact: Guido Rieger, MD(+31-43)
Location Countries  ICMJEAustria,   Czech Republic,   Germany,   Netherlands,   Russian Federation,   Switzerland,   United Arab Emirates

Administrative Information

Responsible PartyMedtronic Bakken Research Center B.V., Medtronic
Study ID Numbers  ICMJECMD 466
Study Sponsor  ICMJEMedtronic BRC
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Despina Voulgaraki, PhDMedtronic Bakken Research Center
Information Provided ByMedtronic BRC