Clinical trial NCT00680927: Reveal® XT Performance Trial (XPECT)
Official title: Reveal® XT Performance Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Risk of Cardiac Arrhythmias
Keywords: Atrial Fibrillation
Risk of cardiac arrhythmias
Loop recorder
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2008-05-20
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Atrial Fibrillation Burden (AF Burden)
timeFrame: 46 hrs
Secondary outcomes:
measure: AF episode detection accuracy and AF episode duration accuracy
timeFrame: 46 hrs
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: LKH - Universitätskliniken
city: Linz
country: Austria
facility: A.ö. Krankenhaus der Elisabethinen Linz
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken
city: Leuven
country: Belgium
facility: University Gasthuisberg
city: Quebec
country: Canada
facility: Hopital Laval
city: Vancouver
country: Canada
facility: St. Paul's Hospital
city: Victoria
country: Canada
facility: Victoria Cardiac Arrhythmia Trials Inc.
city: Brno
country: Czech Republic
facility: Facultni Nemocnice Brno
city: Prague
country: Czech Republic
facility: Nemocnice Na Homolce Hospital
city: Prague
country: Czech Republic
facility: Klinika Kardiologie IKEM
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen, Elektrophysiologie
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik Forschungsgesellschaft
city: Berlin
country: Germany
facility: Charité Campus Mitte
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Leipzig
country: Germany
facility: Universität Leipzig Herzzentrum
city: Tübingen
country: Germany
facility: Medizinische Universitätsklinik Tübingen
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Leiderdorp
country: Netherlands
facility: Rijnland Ziekenhuis
city: Maastricht
country: Netherlands
facility: UMC Maastricht
city: Novosibirsk
country: Russian Federation
facility: Scientific Research Institute of Circulation Pathology
city: St-Petersburg
country: Russian Federation
facility: Almazov Federal Heart, Blood & Endocrinolgoy Centre
city: Banska Bystrica
country: Slovakia
facility: SsUSCH Baska Bystrica
city: Bratislava
country: Slovakia
facility: NUSCH Bratislava a.s.
Study officials:
affiliation: Medtronic Bakken Research Center B.V.
name: Guido H. Rieger, MD
role: STUDY_DIRECTOR
affiliation: Heart Center Leipzig - University Hospital
name: Gerhard Hindricks, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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