Atrial FibrillationNCT00680550
INSIGHT (R)XT. Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT
An observational study of Atrial Fibrillation and Cardiac Arrhythmias, run by Medtronic BRC at 56 sites in 16 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Cardiac Arrhythmias
- How many people
- 1,003 participants
- Where
- 56 sitesin 16 countries
- Study dates
- Apr 2008to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients currently implanted with, or who will be implanted with a Reveal XT Insertable Cardiac Monitor for arrhythmia diagnosis or monitoring.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
56 sites in 16 countries.
56 sites in 16 countries
Germany23 sites
Zentralklinik Bad Berka
Bad Berka
St.-Marien-Hospital
Bonn-Venusberg
Kardiologische Praxis
Burg
Klinikum Coburg
Coburg
Kardiologische Praxis
Dessau
Herzzentrum Dresden
Dresden
Kardiocentrum
Frankfurt
Universitatsklinikum
Freiburg im Breisgau
St. Johannes Hospital
Hagen
Universitares Herzzentrum
Hamburg
Medizinische Hochshule
Hanover
Asklepios Klinik
Harburg
Uniklinik Homburg - Klinik fur Innere Medizin III
Homburg
Herzzentrum, University of Leipzig
Leipzig
Klinik Augustinum
München
Klinikum der Universität München-Großhadern (LMU)
München
Universitätsklinikum Münster
Münster
Klinikum Nürnberg Süd
Nuremberg
St. Martinus Hospital
Olpe
DRK-Krankenhaus Mölln-Ratzeburg
Ratzeburg
Krankenhaus Barmherzige Brueder
Regensburg
Krankenhaus Reinbek, St.-Adolf-Stift
Reinbek
Universitaetsklinikum Tuebingen
Tübingen
Netherlands8 sites
Gelre Apeldoorn
Apeldoorn
Ziekenhuis De Tjongerschans
Heerenveen
Bethesda Ziekenhuis
Hoogeveen
Westfries Gasthuis
Hoorn
Medisch Centrum Leeuwarden
Leeuwarden
Vlietland Ziekenhuis
Schiedam
Maasland Ziekenhuis
Sittard
Diakonessenhuis Utrecht
Utrecht
Switzerland5 sites
Hopital Cantonal de Fribourg
Fribourg
Hopital Cantonal Universitaires de Geneve
Geneva
Hopital de Pourtales de Neuchatel
Neuchâtel
Hopital de Sion CHCVS
Sion
UniversitatsSpital
Zurich
Russia4 sites
Scientific Research Center of Cardio Vascular Surgery by A.N. Bakulev
Moscow
State Research Institute of Circulation Pathology
Novosibirsk
Almazov Federeal Heart, Blood and Endocrinology Centre
Saint Petersburg
Tyumen Cardiology Centre
Tyumen
Austria3 sites
Krankenhaus der Elisabethinen
Linz
Universitätsklinik für Innere Medizin
Vienna
Klinkum Wels-Grieskirchen GmbH
Wels
Czechia3 sites
Fakultni nemocnice Brno
Brno
Fakultni nemocnice u sv. Anny v Brne
Brno
Kardiologicka ambulance
Ostrava
United Arab Emirates1 site
Sheikh Khalifa Medical Center
Abu Dhabi
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation, Cardiac Arrhythmias
- Keywords
- Atrial Fibrillation, Risk of cardiac Arrhythmias, Loop recorder
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
descriptive: clinical indications for Reveal XT
To describe the patient population implanted with a Reveal XT for arrhythmia diagnosis and monitoring
Measured: 2008-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guido Rieger, MD, Study chair, Medtronic Bakken Research Center BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680550
- Sponsor's protocol ID
- CMD 466
- Status last verified
- Oct 2013
- First submitted
- 15 May 2008
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT.
- ClinicalTrials.gov ID
- NCT00680550
- Acronym / sponsor ID
- CMD 466
- Conditions
- Atrial Fibrillation, Cardiac Arrhythmias
- Keywords
- Atrial Fibrillation, Risk of cardiac Arrhythmias, Loop recorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,003 participants (actual)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients currently implanted with, or who will be implanted with a Reveal XT Insertable Cardiac Monitor for arrhythmia diagnosis or monitoring.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
descriptive: clinical indications for Reveal XT
Time frame: 2008-2012
To describe the patient population implanted with a Reveal XT for arrhythmia diagnosis and monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Rieger, MD study chair
Medtronic Bakken Research Center BV
56 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Cardiac Arrhythmias, run by Medtronic BRC at 56 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Germany, Netherlands, Switzerland, Russia, Austria and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
descriptive: clinical indications for Reveal XT (time frame: 2008-2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.