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Atrial FibrillationPhase 4NCT00680927

Reveal® XT Performance Trial (XPECT)

A Phase 4 study testing 46 hrs Holter ECG recording in people with Atrial Fibrillation and Risk of Cardiac Arrhythmias, run by Medtronic BRC at 24 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to quantify the accuracy of the atrial fibrillation diagnostics of the Reveal® XT in a clinical setting and to verify overall system performance, R-wave sensing performance, to obtain user feedback, from both patient and physician, and collect data on device safety. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
46 hrs Holter ECG recording
How many people
247 participants
Where
24 sitesin 8 countries
Study dates
Sep 2007to Aug 2008
Phase
Phase 4
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

Who may be able to join

  • Patient is willing and able to provide his/her informed consent
  • Patient has been implanted with a Reveal® XT
  • Patient fulfills at least one of the following three additional requirements
  • is scheduled for PV ablation or surgical rhythm control intervention, and the PV ablation or surgical intervention can be deferred until study completion or
  • has documented frequent AF or frequent symptoms attributable to AF or
  • has undergone PV ablation within the last 6 months and still has symptoms attributable to AF

Who cannot join

  • Patient has an implanted pacemaker or ICD
  • Patient has persistent or permanent AF
  • Patient is allergic to adhesive ECG electrodes
  • The study will interfere with a therapeutic or diagnostic procedure which is planned or expected during the study period
  • Patient is participating in another study that is expected to compromise the results of this study
  • Patient is a minor, legally incompetent, or does not meet other local requirements for participation in a clinical study
  • Patient is pregnant

Trial locations and contacts

24 sites in 8 countries.

24 sites in 8 countries

Germany7 sites

  • Herzzentrum Bad Krozingen, Elektrophysiologie

    Bad Krozingen, D-79189

  • Kerckhoff Klinik Forschungsgesellschaft

    Bad Nauheim, D-61231

  • Charité Campus Mitte

    Berlin, D-10117

  • Universitätsklinikum Bonn

    Bonn, D-53105

  • Asklepios Klinik St. Georg

    Hamburg, D-20099

  • Universität Leipzig Herzzentrum

    Leipzig

  • Medizinische Universitätsklinik Tübingen

    Tübingen, D-72076

Other trials in Germany

Austria3 sites

  • LKH - Universitätskliniken

    Innsbruck, A-6020

  • A.ö. Krankenhaus der Elisabethinen Linz

    Linz, 4010

  • Salzburger Landeskliniken

    Salzburg, A-5020

Other trials in Austria

Canada3 sites

  • Hopital Laval

    Québec, G1V 4G5

  • St. Paul's Hospital

    Vancouver, V6Z 1Y6

  • Victoria Cardiac Arrhythmia Trials Inc.

    Victoria, V8R 4R2

Other trials in Canada

Czechia3 sites

  • Facultni Nemocnice Brno

    Brno, CZ-625 00

  • Nemocnice Na Homolce Hospital

    Prague, 150 30

  • Klinika Kardiologie IKEM

    Prague, CZ 140-21

Other trials in Czechia

Netherlands3 sites

  • Medisch Centrum Alkmaar

    Alkmaar, 1815 JD

  • Rijnland Ziekenhuis

    Leiderdorp, 2353 GA

  • UMC Maastricht

    Maastricht

Other trials in Netherlands

Russia2 sites

  • Scientific Research Institute of Circulation Pathology

    Novosibirsk, 630055

  • Almazov Federal Heart, Blood & Endocrinolgoy Centre

    Saint Petersburg, 197341

Other trials in Russia

Slovakia2 sites

  • SsUSCH Baska Bystrica

    Banská Bystrica, 974 01

  • NUSCH Bratislava a.s.

    Bratislava, 833 48

Other trials in Slovakia

Belgium1 site

  • University Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

About this study

Official title: Reveal® XT Performance Trial

The purpose of this study is to quantify the accuracy of the atrial fibrillation diagnostics of the Reveal® XT in a clinical setting and to verify overall system performance, R-wave sensing performance, to obtain user feedback, from both patient and physician, and collect data on device safety.

Read the detailed description

The study is a prospective, non-randomized, multi-center international post-market study.

The study will be conducted at 20-30 centers primarily in Europe. The study will be conducted at least in Germany, Austria, Switzerland, The Netherlands, and the Czech Republic. Study centers from Canada may also participate, depending on the timelines for regulatory approval and commercial release of the Reveal® XT in this region.

It is expected that between 140 and 200 patients will be enrolled to ensure that at least 47 patients are included to assess the first primary objective and at least 60 patients to assess the second primary objective.

The primary objective is to quantify the AF detection performance of the device.

The patient population will be assessed in two separate cohorts. The first primary objective is to quantify the 24-hour AF burden accuracy in patients with more than 1% AF burden.

The second primary objective is to quantify the detection accuracy of non-arrhythmia in patients with 1% or less AF burden.

Being tested
46 hrs Holter ECG recording
Keywords
Atrial Fibrillation, Risk of cardiac arrhythmias, Loop recorder
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 46 hrs Holter ECG recordingOther

    Maximum of 2 46 hrs external Holter ECG recordings are required.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Atrial Fibrillation Burden (AF Burden)

    Measured: 46 hrs

Secondary outcomes (1)

  1. AF episode detection accuracy and AF episode duration accuracy

    Measured: 46 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionAug 2008
  4. Study completionAug 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00680927
Sponsor's protocol ID
CMD 446
Status last verified
Jan 2009
First submitted
15 May 2008
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Nergardh A, Frick M. Perceived heart rhythm in relation to ECG findings after direct current cardioversion of atrial fibrillation. Heart. 2006 Sep;92(9):1244-7. doi: 10.1136/hrt.2005.082156. Epub 2006 Mar 17.

    PubMed 16547207

  • Hindricks G, Piorkowski C, Tanner H, Kobza R, Gerds-Li JH, Carbucicchio C, Kottkamp H. Perception of atrial fibrillation before and after radiofrequency catheter ablation: relevance of asymptomatic arrhythmia recurrence. Circulation. 2005 Jul 19;112(3):307-13. doi: 10.1161/CIRCULATIONAHA.104.518837. Epub 2005 Jul 11.

    PubMed 16009793

  • Kimman GJ, Theuns DA, Janse PA, Rivero-Ayerza M, Scholten MF, Szili-Torok T, Jordaens LJ. One-year follow-up in a prospective, randomized study comparing radiofrequency and cryoablation of arrhythmias in Koch's triangle: clinical symptoms and event recording. Europace. 2006 Aug;8(8):592-5. doi: 10.1093/europace/eul051. Epub 2006 Jun 27.

    PubMed 16803840

  • Senatore G, Stabile G, Bertaglia E, Donnici G, De Simone A, Zoppo F, Turco P, Pascotto P, Fazzari M. Role of transtelephonic electrocardiographic monitoring in detecting short-term arrhythmia recurrences after radiofrequency ablation in patients with atrial fibrillation. J Am Coll Cardiol. 2005 Mar 15;45(6):873-6. doi: 10.1016/j.jacc.2004.11.050.

    PubMed 15766823

  • Patten M, Maas R, Karim A, Muller HW, Simonovsky R, Meinertz T. Event-recorder monitoring in the diagnosis of atrial fibrillation in symptomatic patients: subanalysis of the SOPAT trial. J Cardiovasc Electrophysiol. 2006 Nov;17(11):1216-20. doi: 10.1111/j.1540-8167.2006.00609.x. Epub 2006 Sep 20.

    PubMed 16987384

  • Fetsch T, Bauer P, Engberding R, Koch HP, Lukl J, Meinertz T, Oeff M, Seipel L, Trappe HJ, Treese N, Breithardt G; Prevention of Atrial Fibrillation after Cardioversion Investigators. Prevention of atrial fibrillation after cardioversion: results of the PAFAC trial. Eur Heart J. 2004 Aug;25(16):1385-94. doi: 10.1016/j.ehj.2004.04.015.

    PubMed 15302102

  • Kottkamp H, Tanner H, Kobza R, Schirdewahn P, Dorszewski A, Gerds-Li JH, Carbucicchio C, Piorkowski C, Hindricks G. Time courses and quantitative analysis of atrial fibrillation episode number and duration after circular plus linear left atrial lesions: trigger elimination or substrate modification: early or delayed cure? J Am Coll Cardiol. 2004 Aug 18;44(4):869-77. doi: 10.1016/j.jacc.2004.04.049.

    PubMed 15312874

  • Israel CW, Gronefeld G, Ehrlich JR, Li YG, Hohnloser SH. Long-term risk of recurrent atrial fibrillation as documented by an implantable monitoring device: implications for optimal patient care. J Am Coll Cardiol. 2004 Jan 7;43(1):47-52. doi: 10.1016/j.jacc.2003.08.027.

    PubMed 14715182

  • Strickberger SA, Ip J, Saksena S, Curry K, Bahnson TD, Ziegler PD. Relationship between atrial tachyarrhythmias and symptoms. Heart Rhythm. 2005 Feb;2(2):125-31. doi: 10.1016/j.hrthm.2004.10.042.

    PubMed 15851283

  • Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm. 2006 Dec;3(12):1445-52. doi: 10.1016/j.hrthm.2006.07.030. Epub 2006 Aug 3.

    PubMed 17161787

  • Israel CW, Neubauer H, Olbrich HG, Hartung W, Treusch S, Hohnloser SH; BEATS Study Investigators. Incidence of atrial tachyarrhythmias in pacemaker patients: results from the Balanced Evaluation of Atrial Tachyarrhythmias in Stimulated patients (BEATS) study. Pacing Clin Electrophysiol. 2006 Jun;29(6):582-8. doi: 10.1111/j.1540-8159.2006.00405.x.

    PubMed 16784423

  • Joshi AK, Kowey PR, Prystowsky EN, Benditt DG, Cannom DS, Pratt CM, McNamara A, Sangrigoli RM. First experience with a Mobile Cardiac Outpatient Telemetry (MCOT) system for the diagnosis and management of cardiac arrhythmia. Am J Cardiol. 2005 Apr 1;95(7):878-81. doi: 10.1016/j.amjcard.2004.12.015.

    PubMed 15781022

  • Vasamreddy CR, Dalal D, Dong J, Cheng A, Spragg D, Lamiy SZ, Meininger G, Henrikson CA, Marine JE, Berger R, Calkins H. Symptomatic and asymptomatic atrial fibrillation in patients undergoing radiofrequency catheter ablation. J Cardiovasc Electrophysiol. 2006 Feb;17(2):134-9. doi: 10.1111/j.1540-8167.2006.00359.x.

    PubMed 16533249

  • Hindricks G, Pokushalov E, Urban L, Taborsky M, Kuck KH, Lebedev D, Rieger G, Purerfellner H; XPECT Trial Investigators. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol. 2010 Apr;3(2):141-7. doi: 10.1161/CIRCEP.109.877852. Epub 2010 Feb 16.

    PubMed 20160169

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 46 hrs Holter ECG recording in people with Atrial Fibrillation and Risk of Cardiac Arrhythmias, run by Medtronic BRC at 24 sites in 8 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 6 inclusion and 7 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 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Germany, Austria, Canada, Czechia, Netherlands and 3 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Atrial Fibrillation Burden (AF Burden) (time frame: 46 hrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00680927, which also lists 14 linked publications.

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 3 Jun 2015.

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