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

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 1003

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria
    • Krankenhaus der Elisabethinen
  • Wels, Austria
    • Klinkum Wels-Grieskirchen GmbH
  • Wien, Austria
    • Universitätsklinik für Innere Medizin
• Belarus
  • Minsk, Belarus
    • Republican Scientific Practical Center
• Czech Republic
  • Brno, Czech Republic
    • Fakultní Nemocnice Brno
  • Brno, Czech Republic
    • Fakultni Nemocnice u sv. Anny v Brne
  • Ostrava, Czech Republic
    • Kardiologicka ambulance
• Finland
  • Tampere, Finland
    • Tampere University Hospital
• Germany
  • Bad Berka, Germany
    • Zentralklinik Bad Berka
  • Bonn-Venusberg, Germany
    • St.-Marien-Hospital
  • Burg, Germany
    • Kardiologische Praxis
  • Coburg, Germany
    • Klinikum Coburg
  • Dessau, Germany
    • Kardiologische Praxis
  • Dresden, Germany
    • Herzzentrum Dresden
  • Frankfurt, Germany
    • Kardiocentrum
  • Freiburg, Germany
    • Universitätsklinikum
  • Hagen, Germany
    • St. Johannes Hospital
  • Hamburg, Germany
    • Universitäres Herzzentrum
  • Hamburg-Harburg, Germany
    • Asklepios Klinik
  • Hannover, Germany
    • Medizinische Hochshule
  • Homburg, Germany
    • Uniklinik Homburg - Klinik fur Innere Medizin III
  • Leipzig, Germany
    • Herzzentrum, University of Leipzig
  • München, Germany
    • Klinik Augustinum
  • München, Germany
    • Klinikum der Universität München-Großhadern (LMU)
  • Münster, Germany
    • Universitätsklinikum Münster
  • Nürnberg, Germany
    • Klinikum Nürnberg Süd
  • Olpe, Germany
    • St. Martinus Hospital
  • Ratzeburg, Germany
    • DRK-Krankenhaus Mölln-Ratzeburg
  • Regensburg, Germany
    • Krankenhaus Barmherzige Brueder
  • Reinbek, Germany
    • Krankenhaus Reinbek, St.-Adolf-Stift
  • Tuebingen, Germany
    • Universitaetsklinikum Tuebingen
• Italy
  • Florence, Italy
    • Azienda Ospedaliera Universitaria Careggi
• Netherlands
  • Apeldoorn, Netherlands
    • Gelre Apeldoorn
  • Heerenveen, Netherlands
    • Ziekenhuis De Tjongerschans
  • Hoogeveen, Netherlands
    • Bethesda Ziekenhuis
  • Hoorn, Netherlands
    • Westfries Gasthuis
  • Leeuwarden, Netherlands
    • Medisch Centrum Leeuwarden
  • Schiedam, Netherlands
    • Vlietland ziekenhuis
  • Sittard, Netherlands
    • Maasland Ziekenhuis
  • Utrecht, Netherlands
    • Diakonessenhuis Utrecht
• Portugal
  • Porto, Portugal
    • Centro Hospitalar do Porto - Hospital de Santo António
• Russian Federation
  • Moscow, Russian Federation
    • Scientific Research Center of Cardio Vascular Surgery by A.N. Bakulev
  • Novosibirsk, Russian Federation
    • State Research Institute of Circulation Pathology
  • St. Petersburg, Russian Federation
    • Almazov Federeal Heart, Blood and Endocrinology Centre
  • Tyumen, Russian Federation
    • Tyumen Cardiology Centre
• Slovakia
  • Kosice, Slovakia
    • Arytmologicke oddelenie VUSCH
• Slovenia
  • Ljubljana, Slovenia
    • University Medical Center Ljubljana
• Spain
  • Vigo, Spain
    • Complejo Hospitalario Universitario de Vigo
• Sweden
  • Örebro, Sweden
    • University hospital Örebro
• Switzerland
  • Fribourg, Switzerland
    • Hôpital Cantonal de Fribourg
  • Geneve, Switzerland
    • Hopital Cantonal Universitaires de Geneve
  • Neuchatel, Switzerland
    • Hopital de Pourtales de Neuchatel
  • Sion, Switzerland
    • Hopital de Sion CHCVS
  • Zurich, Switzerland
    • Universitätsspital
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Sheikh Khalifa Medical Center
• United Kingdom
  • Liverpool, United Kingdom
    • Liverpool Heart and Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
descriptive: clinical indications for Reveal XT	To describe the patient population implanted with a Reveal XT for arrhythmia diagnosis and monitoring	2008-2012

Collaborators and Investigators

• Sponsor: Medtronic BRC
• Investigators: Study Chair: Guido Rieger, MD, Medtronic Bakken Research Center BV

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: May 15, 2008
• First Submitted That Met QC Criteria: May 19, 2008
• First Posted (Estimate): May 20, 2008

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 15, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Loop recorder; Risk of cardiac Arrhythmias
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: CMD 466