INSIGHT (R)XT. Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT
Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT.
1 other identifier
observational
1,003
15 countries
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2008
Longer than P75 for all trials
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 15, 2008
CompletedFirst Posted
Study publicly available on registry
May 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedOctober 16, 2013
October 1, 2013
5 years
May 15, 2008
October 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
descriptive: clinical indications for Reveal XT
To describe the patient population implanted with a Reveal XT for arrhythmia diagnosis and monitoring
2008-2012
Eligibility Criteria
Patients currently implanted with, or who will be implanted with a Reveal XT Insertable Cardiac Monitor for arrhythmia diagnosis or monitoring.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic BRClead
Study Sites (56)
Krankenhaus der Elisabethinen
Linz, Austria
Universitätsklinik für Innere Medizin
Vienna, Austria
Klinkum Wels-Grieskirchen GmbH
Wels, Austria
Republican Scientific Practical Center
Minsk, Belarus
Fakultni nemocnice Brno
Brno, Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia
Kardiologicka ambulance
Ostrava, Czechia
Tampere University Hospital
Tampere, Finland
Zentralklinik Bad Berka
Bad Berka, Germany
St.-Marien-Hospital
Bonn-Venusberg, Germany
Kardiologische Praxis
Burg, Germany
Klinikum Coburg
Coburg, Germany
Kardiologische Praxis
Dessau, Germany
Herzzentrum Dresden
Dresden, Germany
Kardiocentrum
Frankfurt, Germany
Universitatsklinikum
Freiburg im Breisgau, Germany
St. Johannes Hospital
Hagen, Germany
Universitares Herzzentrum
Hamburg, Germany
Medizinische Hochshule
Hanover, Germany
Asklepios Klinik
Harburg, Germany
Uniklinik Homburg - Klinik fur Innere Medizin III
Homburg, Germany
Herzzentrum, University of Leipzig
Leipzig, Germany
Klinik Augustinum
München, Germany
Klinikum der Universität München-Großhadern (LMU)
München, Germany
Universitätsklinikum Münster
Münster, Germany
Klinikum Nürnberg Süd
Nuremberg, Germany
St. Martinus Hospital
Olpe, Germany
DRK-Krankenhaus Mölln-Ratzeburg
Ratzeburg, Germany
Krankenhaus Barmherzige Brueder
Regensburg, Germany
Krankenhaus Reinbek, St.-Adolf-Stift
Reinbek, Germany
Universitaetsklinikum Tuebingen
Tübingen, Germany
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Gelre Apeldoorn
Apeldoorn, Netherlands
Ziekenhuis De Tjongerschans
Heerenveen, Netherlands
Bethesda Ziekenhuis
Hoogeveen, Netherlands
Westfries Gasthuis
Hoorn, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Vlietland Ziekenhuis
Schiedam, Netherlands
Maasland Ziekenhuis
Sittard, Netherlands
Diakonessenhuis Utrecht
Utrecht, Netherlands
Centro Hospitalar do Porto - Hospital de Santo Antonio
Porto, Portugal
Scientific Research Center of Cardio Vascular Surgery by A.N. Bakulev
Moscow, Russia
State Research Institute of Circulation Pathology
Novosibirsk, Russia
Almazov Federeal Heart, Blood and Endocrinology Centre
Saint Petersburg, Russia
Tyumen Cardiology Centre
Tyumen, Russia
Arytmologicke oddelenie VUSCH
Košice, Slovakia
University Medical Center Ljubljana
Ljubljana, Slovenia
Complejo Hospitalario Universitario de Vigo
Vigo, Spain
University Hospital Örebro
Örebro, Sweden
Hopital Cantonal de Fribourg
Fribourg, Switzerland
Hopital Cantonal Universitaires de Geneve
Geneva, Switzerland
Hopital de Pourtales de Neuchatel
Neuchâtel, Switzerland
Hopital de Sion CHCVS
Sion, Switzerland
UniversitatsSpital
Zurich, Switzerland
Sheikh Khalifa Medical Center
Abu Dhabi, United Arab Emirates
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guido Rieger, MD
Medtronic Bakken Research Center BV
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2008
First Posted
May 20, 2008
Study Start
April 1, 2008
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
October 16, 2013
Record last verified: 2013-10