Reveal® XT Performance Trial (XPECT)

Atrial Fibrillation Clinical Trial

Official title:

Reveal® XT Performance Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680927
• Other study ID #: CMD 446
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2008
• Last updated: June 2, 2015
• Start date: September 2007
• Est. completion date: August 2008

Study information

• Verified date: January 2009
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Slovakia: State Institute for Drug ControlCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

1. is scheduled for PV ablation or surgical rhythm control intervention, and the PV ablation or surgical intervention can be deferred until study completion or

2. has documented frequent AF or frequent symptoms attributable to AF or

3. has undergone PV ablation within the last 6 months and still has symptoms attributable to AF

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Risk of Cardiac Arrhythmias

Intervention

Other:
• 46 hrs Holter ECG recording
Maximum of 2 46 hrs external Holter ECG recordings are required.

Locations

Country	Name	City	State
Austria	LKH - Universitätskliniken	Innsbruck
Austria	A.ö. Krankenhaus der Elisabethinen Linz	Linz
Austria	Salzburger Landeskliniken	Salzburg
Belgium	University Gasthuisberg	Leuven
Canada	Hopital Laval	Quebec
Canada	St. Paul's Hospital	Vancouver
Canada	Victoria Cardiac Arrhythmia Trials Inc.	Victoria
Czech Republic	Facultni Nemocnice Brno	Brno
Czech Republic	Klinika Kardiologie IKEM	Prague
Czech Republic	Nemocnice Na Homolce Hospital	Prague
Germany	Herzzentrum Bad Krozingen, Elektrophysiologie	Bad Krozingen
Germany	Kerckhoff Klinik Forschungsgesellschaft	Bad Nauheim
Germany	Charité Campus Mitte	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Universität Leipzig Herzzentrum	Leipzig
Germany	Medizinische Universitätsklinik Tübingen	Tübingen
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Netherlands	Rijnland Ziekenhuis	Leiderdorp
Netherlands	UMC Maastricht	Maastricht
Russian Federation	Scientific Research Institute of Circulation Pathology	Novosibirsk
Russian Federation	Almazov Federal Heart, Blood & Endocrinolgoy Centre	St-Petersburg
Slovakia	SsUSCH Baska Bystrica	Banska Bystrica
Slovakia	NUSCH Bratislava a.s.	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czech Republic,  Germany,  Netherlands,  Russian Federation,  Slovakia, 

References & Publications (13)

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. — View Citation

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. Epub 2005 Jul 11. — View Citation

Israel CW, Grönefeld 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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Jun 27. — View Citation

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. — View Citation

Nergårdh 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. Epub 2006 Mar 17. — View Citation

Patten M, Maas R, Karim A, Müller 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. Epub 2006 Sep 20. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm. 2006 Dec;3(12):1445-52. Epub 2006 Aug 3. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial Fibrillation Burden (AF Burden)		46 hrs	No
Secondary	AF episode detection accuracy and AF episode duration accuracy		46 hrs	No