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

Official Title: “Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT.”

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.

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.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Medtronic BRC Industry

Overall Clinical Trial Officials and Contacts

Guido Rieger, MD Study Chair Medtronic Bakken Research Center  

Overall Contact: Guido Rieger, MD (+31-43) 3566844 guido.rieger@medtronic.com

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00680550

Study ID Number: CMD 466

ClinicalTrials.gov Identifier: NCT00680550

Health Authority: Germany: Federal Institute for Drugs and Medical Devices