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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic BRC
ClinicalTrials.gov Identifier:
NCT00680550
First received: May 15, 2008
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Atrial Fibrillation
Risk of Cardiac Arrhythmias

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic BRC:

Estimated Enrollment: 800
Study Start Date: April 2008
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680550

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

No publications provided

Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT00680550     History of Changes
Other Study ID Numbers: CMD 466
Study First Received: May 15, 2008
Last Updated: May 10, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on May 16, 2013