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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680550
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):
Medtronic BRC

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.

Condition or disease
Atrial Fibrillation Cardiac Arrhythmias

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 60-100 centers primarily in Europe. It is expected that 800-1000 patients will be enrolled.

Study Type : Observational
Actual Enrollment : 1003 participants
Time Perspective: Prospective
Official Title: Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT.
Study Start Date : April 2008
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. descriptive: clinical indications for Reveal XT [ Time Frame: 2008-2012 ]
    To describe the patient population implanted with a Reveal XT for arrhythmia diagnosis and monitoring

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients currently implanted with, or who will be implanted with a Reveal XT Insertable Cardiac Monitor for arrhythmia diagnosis or monitoring.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680550

  Show 56 Study Locations
Sponsors and Collaborators
Medtronic BRC
Study Chair: Guido Rieger, MD Medtronic Bakken Research Center BV

Responsible Party: Medtronic BRC Identifier: NCT00680550     History of Changes
Other Study ID Numbers: CMD 466
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

Keywords provided by Medtronic BRC:
Atrial Fibrillation
Risk of cardiac Arrhythmias
Loop recorder

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes