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

Atrial Fibrillation Clinical Trial

Official title:

Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680550
• Other study ID #: CMD 466
• Status: Completed
• Phase: N/A
• First received: May 15, 2008
• Last updated: October 15, 2013
• Start date: April 2008
• Est. completion date: April 2013

Study information

• Verified date: October 2013
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1003
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiac Arrhythmias

Locations

Country	Name	City	State
Austria	Krankenhaus der Elisabethinen	Linz
Austria	Klinkum Wels-Grieskirchen GmbH	Wels
Austria	Universitätsklinik für Innere Medizin	Wien
Belarus	Republican Scientific Practical Center	Minsk
Czech Republic	Fakultni nemocnice Brno	Brno
Czech Republic	Fakultni nemocnice u sv. Anny v Brne	Brno
Czech Republic	Kardiologicka ambulance	Ostrava
Finland	Tampere University Hospital	Tampere
Germany	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
Germany	St. Johannes Hospital	Hagen
Germany	Universitares Herzzentrum	Hamburg
Germany	Asklepios Klinik	Hamburg-Harburg
Germany	Medizinische Hochshule	Hannover
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	Nürnberg
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	Tuebingen
Italy	Azienda Ospedaliera Universitaria Careggi	Florence
Netherlands	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
Portugal	Centro Hospitalar do Porto - Hospital de Santo Antonio	Porto
Russian Federation	Scientific Research Center of Cardio Vascular Surgery by A.N. Bakulev	Moscow
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk
Russian Federation	Almazov Federeal Heart, Blood and Endocrinology Centre	St. Petersburg
Russian Federation	Tyumen Cardiology Centre	Tyumen
Slovakia	Arytmologicke oddelenie VUSCH	Kosice
Slovenia	University Medical Center Ljubljana	Ljubljana
Spain	Complejo Hospitalario Universitario de Vigo	Vigo
Sweden	University Hospital Örebro	Örebro
Switzerland	Hopital Cantonal de Fribourg	Fribourg
Switzerland	Hopital Cantonal Universitaires de Geneve	Geneve
Switzerland	Hopital de Pourtales de Neuchatel	Neuchatel
Switzerland	Hopital de Sion CHCVS	Sion
Switzerland	UniversitatsSpital	Zurich
United Arab Emirates	Sheikh Khalifa Medical Center	Abu Dhabi
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Countries where clinical trial is conducted

Austria,  Belarus,  Czech Republic,  Finland,  Germany,  Italy,  Netherlands,  Portugal,  Russian Federation,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	descriptive: clinical indications for Reveal XT	To describe the patient population implanted with a Reveal XT for arrhythmia diagnosis and monitoring	2008-2012	No