Clinical trial NCT00680550: INSIGHT (R)XT. Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT
Official title: Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Cardiac Arrhythmias
Keywords: Atrial Fibrillation
Risk of cardiac Arrhythmias
Loop recorder
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2008-05-20
Enrollment: 1003
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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

Eligibility 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

Primary outcomes:
measure: descriptive: clinical indications for Reveal XT
timeFrame: 2008-2012
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen
city: Wels
country: Austria
facility: Klinkum Wels-Grieskirchen GmbH
city: Wien
country: Austria
facility: Universitätsklinik für Innere Medizin
city: Minsk
country: Belarus
facility: Republican Scientific Practical Center
city: Brno
country: Czech Republic
facility: Fakultni nemocnice Brno
city: Brno
country: Czech Republic
facility: Fakultni nemocnice u sv. Anny v Brne
city: Ostrava
country: Czech Republic
facility: Kardiologicka ambulance
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Bonn-Venusberg
country: Germany
facility: St.-Marien-Hospital
city: Burg
country: Germany
facility: Kardiologische Praxis
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Dessau
country: Germany
facility: Kardiologische Praxis
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Frankfurt
country: Germany
facility: Kardiocentrum
city: Freiburg
country: Germany
facility: Universitatsklinikum
city: Hagen
country: Germany
facility: St. Johannes Hospital
city: Hamburg-Harburg
country: Germany
facility: Asklepios Klinik
city: Hamburg
country: Germany
facility: Universitares Herzzentrum
city: Hannover
country: Germany
facility: Medizinische Hochshule
city: Homburg
country: Germany
facility: Uniklinik Homburg - Klinik fur Innere Medizin III
city: Leipzig
country: Germany
facility: Herzzentrum, University of Leipzig
city: München
country: Germany
facility: Klinik Augustinum
city: München
country: Germany
facility: Klinikum der Universität München-Großhadern (LMU)
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
city: Olpe
country: Germany
facility: St. Martinus Hospital
city: Ratzeburg
country: Germany
facility: DRK-Krankenhaus Mölln-Ratzeburg
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brueder
city: Reinbek
country: Germany
facility: Krankenhaus Reinbek, St.-Adolf-Stift
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Florence
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Apeldoorn
country: Netherlands
facility: Gelre Apeldoorn
city: Heerenveen
country: Netherlands
facility: Ziekenhuis De Tjongerschans
city: Hoogeveen
country: Netherlands
facility: Bethesda Ziekenhuis
city: Hoorn
country: Netherlands
facility: Westfries Gasthuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Schiedam
country: Netherlands
facility: Vlietland Ziekenhuis
city: Sittard
country: Netherlands
facility: Maasland Ziekenhuis
city: Utrecht
country: Netherlands
facility: Diakonessenhuis Utrecht
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto - Hospital de Santo Antonio
city: Moscow
country: Russian Federation
facility: Scientific Research Center of Cardio Vascular Surgery by A.N. Bakulev
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
city: St. Petersburg
country: Russian Federation
facility: Almazov Federeal Heart, Blood and Endocrinology Centre
city: Tyumen
country: Russian Federation
facility: Tyumen Cardiology Centre
city: Kosice
country: Slovakia
facility: Arytmologicke oddelenie VUSCH
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
city: Örebro
country: Sweden
facility: University Hospital Örebro
city: Fribourg
country: Switzerland
facility: Hopital Cantonal de Fribourg
city: Geneve
country: Switzerland
facility: Hopital Cantonal Universitaires de Geneve
city: Neuchatel
country: Switzerland
facility: Hopital de Pourtales de Neuchatel
city: Sion
country: Switzerland
facility: Hopital de Sion CHCVS
city: Zurich
country: Switzerland
facility: UniversitatsSpital
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Khalifa Medical Center
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
Study officials:
affiliation: Medtronic Bakken Research Center BV
name: Guido Rieger, MD
role: STUDY_CHAIR
References: