Reveal® XT Performance Trial (XPECT)

NCT00680927 | Completed Phase 4

• 1 other identifier: CMD 446
• Study Type: interventional
• Target: 247
• Locations: 8 countries
• Sites: 24

Brief 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.

Conditions

Atrial Fibrillation; Risk of Cardiac Arrhythmias

Keywords

Atrial Fibrillation; Risk of cardiac arrhythmias; Loop recorder

Outcome Measures

Primary Outcomes (1)

• Atrial Fibrillation Burden (AF Burden)

  46 hrs

Secondary Outcomes (1)

• AF episode detection accuracy and AF episode duration accuracy

  46 hrs

Interventions

46 hrs Holter ECG recording OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic BRC: lead

Study Sites (24)

LKH - Universitätskliniken

Innsbruck, A-6020, Austria

Location

A.ö. Krankenhaus der Elisabethinen Linz

Linz, 4010, Austria

Location

Salzburger Landeskliniken

Salzburg, A-5020, Austria

Location

University Gasthuisberg

Leuven, B-3000, Belgium

Location

Hopital Laval

Québec, G1V 4G5, Canada

Location

St. Paul's Hospital

Vancouver, V6Z 1Y6, Canada

Location

Victoria Cardiac Arrhythmia Trials Inc.

Victoria, V8R 4R2, Canada

Location

Facultni Nemocnice Brno

Brno, CZ-625 00, Czechia

Location

Nemocnice Na Homolce Hospital

Prague, 150 30, Czechia

Location

Klinika Kardiologie IKEM

Prague, CZ 140-21, Czechia

Location

Herzzentrum Bad Krozingen, Elektrophysiologie

Bad Krozingen, D-79189, Germany

Location

Kerckhoff Klinik Forschungsgesellschaft

Bad Nauheim, D-61231, Germany

Location

Charité Campus Mitte

Berlin, D-10117, Germany

Location

Universitätsklinikum Bonn

Bonn, D-53105, Germany

Location

Asklepios Klinik St. Georg

Hamburg, D-20099, Germany

Location

Universität Leipzig Herzzentrum

Leipzig, Germany

Location

Medizinische Universitätsklinik Tübingen

Tübingen, D-72076, Germany

Location

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

Rijnland Ziekenhuis

Leiderdorp, 2353 GA, Netherlands

Location

UMC Maastricht

Maastricht, Netherlands

Location

Scientific Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

Almazov Federal Heart, Blood & Endocrinolgoy Centre

Saint Petersburg, 197341, Russia

Location

SsUSCH Baska Bystrica

Banská Bystrica, 974 01, Slovakia

Location

NUSCH Bratislava a.s.

Bratislava, 833 48, Slovakia

Location

Related Publications (14)

• 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.

  PMID: 16547207 BACKGROUND

• 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.

  PMID: 16009793 BACKGROUND

• 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.

  PMID: 16803840 BACKGROUND

• 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.

  PMID: 15766823 BACKGROUND

• 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.

  PMID: 16987384 BACKGROUND

• 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.

  PMID: 15302102 BACKGROUND

• 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.

  PMID: 15312874 BACKGROUND

• 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.

  PMID: 14715182 BACKGROUND

• 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.

  PMID: 15851283 BACKGROUND

• 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.

  PMID: 17161787 BACKGROUND

• 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.

  PMID: 16784423 BACKGROUND

• 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.

  PMID: 15781022 BACKGROUND

• 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.

  PMID: 16533249 BACKGROUND

• 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.

  PMID: 20160169 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guido H. Rieger, MD

  Medtronic Bakken Research Center B.V.

  STUDY DIRECTOR

• Gerhard Hindricks, MD, PhD

  Heart Center Leipzig - University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 20, 2008
• Study Start: September 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: June 3, 2015

Record last verified: 2009-01

Locations

RU (2); AU (3); CA (3); CZ (3); SL (2); BE (1); DE (7); NL (3)