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

NCT ID: NCT00680550

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1003 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-04-30

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Cardiac Arrhythmias

Keywords

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Atrial Fibrillation Risk of cardiac Arrhythmias Loop recorder

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic BRC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guido Rieger, MD

Role: STUDY_CHAIR

Medtronic Bakken Research Center BV

Locations

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Krankenhaus der Elisabethinen

Linz, , Austria

Site Status

Universitätsklinik für Innere Medizin

Vienna, , Austria

Site Status

Klinkum Wels-Grieskirchen GmbH

Wels, , Austria

Site Status

Republican Scientific Practical Center

Minsk, , Belarus

Site Status

Fakultni nemocnice Brno

Brno, , Czechia

Site Status

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Site Status

Kardiologicka ambulance

Ostrava, , Czechia

Site Status

Tampere University Hospital

Tampere, , Finland

Site Status

Zentralklinik Bad Berka

Bad Berka, , Germany

Site Status

St.-Marien-Hospital

Bonn-Venusberg, , Germany

Site Status

Kardiologische Praxis

Burg, , Germany

Site Status

Klinikum Coburg

Coburg, , Germany

Site Status

Kardiologische Praxis

Dessau, , Germany

Site Status

Herzzentrum Dresden

Dresden, , Germany

Site Status

Kardiocentrum

Frankfurt, , Germany

Site Status

Universitatsklinikum

Freiburg im Breisgau, , Germany

Site Status

St. Johannes Hospital

Hagen, , Germany

Site Status

Universitares Herzzentrum

Hamburg, , Germany

Site Status

Medizinische Hochshule

Hanover, , Germany

Site Status

Asklepios Klinik

Harburg, , Germany

Site Status

Uniklinik Homburg - Klinik fur Innere Medizin III

Homburg, , Germany

Site Status

Herzzentrum, University of Leipzig

Leipzig, , Germany

Site Status

Klinik Augustinum

München, , Germany

Site Status

Klinikum der Universität München-Großhadern (LMU)

München, , Germany

Site Status

Universitätsklinikum Münster

Münster, , Germany

Site Status

Klinikum Nürnberg Süd

Nuremberg, , Germany

Site Status

St. Martinus Hospital

Olpe, , Germany

Site Status

DRK-Krankenhaus Mölln-Ratzeburg

Ratzeburg, , Germany

Site Status

Krankenhaus Barmherzige Brueder

Regensburg, , Germany

Site Status

Krankenhaus Reinbek, St.-Adolf-Stift

Reinbek, , Germany

Site Status

Universitaetsklinikum Tuebingen

Tübingen, , Germany

Site Status

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Site Status

Gelre Apeldoorn

Apeldoorn, , Netherlands

Site Status

Ziekenhuis De Tjongerschans

Heerenveen, , Netherlands

Site Status

Bethesda Ziekenhuis

Hoogeveen, , Netherlands

Site Status

Westfries Gasthuis

Hoorn, , Netherlands

Site Status

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Site Status

Vlietland Ziekenhuis

Schiedam, , Netherlands

Site Status

Maasland Ziekenhuis

Sittard, , Netherlands

Site Status

Diakonessenhuis Utrecht

Utrecht, , Netherlands

Site Status

Centro Hospitalar do Porto - Hospital de Santo Antonio

Porto, , Portugal

Site Status

Scientific Research Center of Cardio Vascular Surgery by A.N. Bakulev

Moscow, , Russia

Site Status

State Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status

Almazov Federeal Heart, Blood and Endocrinology Centre

Saint Petersburg, , Russia

Site Status

Tyumen Cardiology Centre

Tyumen, , Russia

Site Status

Arytmologicke oddelenie VUSCH

Košice, , Slovakia

Site Status

University Medical Center Ljubljana

Ljubljana, , Slovenia

Site Status

Complejo Hospitalario Universitario de Vigo

Vigo, , Spain

Site Status

University Hospital Örebro

Örebro, , Sweden

Site Status

Hopital Cantonal de Fribourg

Fribourg, , Switzerland

Site Status

Hopital Cantonal Universitaires de Geneve

Geneva, , Switzerland

Site Status

Hopital de Pourtales de Neuchatel

Neuchâtel, , Switzerland

Site Status

Hopital de Sion CHCVS

Sion, , Switzerland

Site Status

UniversitatsSpital

Zurich, , Switzerland

Site Status

Sheikh Khalifa Medical Center

Abu Dhabi, , United Arab Emirates

Site Status

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Site Status

Countries

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Austria Belarus Czechia Finland Germany Italy Netherlands Portugal Russia Slovakia Slovenia Spain Sweden Switzerland United Arab Emirates United Kingdom

Other Identifiers

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CMD 466

Identifier Type: -

Identifier Source: org_study_id