Reveal® XT Performance Trial (XPECT)

June 2, 2015 updated by: Medtronic BRC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

247

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, A-6020
        • LKH - Universitätskliniken
      • Linz, Austria, 4010
        • A.ö. Krankenhaus der Elisabethinen Linz
      • Salzburg, Austria, A-5020
        • Salzburger Landeskliniken
  • Belgium
      • Leuven, Belgium, B-3000
        • University Gasthuisberg
  • Canada
      • Quebec, Canada, G1V 4G5
        • Hôpital Laval
      • Vancouver, Canada, V6Z 1Y6
        • St. Paul's Hospital
      • Victoria, Canada, V8R 4R2
        • Victoria Cardiac Arrhythmia Trials Inc.
  • Czech Republic
      • Brno, Czech Republic, CZ-625 00
        • Facultni Nemocnice Brno
      • Prague, Czech Republic, 150 30
        • Nemocnice Na Homolce Hospital
      • Prague, Czech Republic, CZ 140-21
        • Klinika Kardiologie IKEM
  • Germany
      • Bad Krozingen, Germany, D-79189
        • Herzzentrum Bad Krozingen, Elektrophysiologie
      • Bad Nauheim, Germany, D-61231
        • Kerckhoff Klinik Forschungsgesellschaft
      • Berlin, Germany, D-10117
        • Charité Campus Mitte
      • Bonn, Germany, D-53105
        • Universitätsklinikum Bonn
      • Hamburg, Germany, D-20099
        • Asklepios Klinik St. Georg
      • Leipzig, Germany
        • Universität Leipzig Herzzentrum
      • Tübingen, Germany, D-72076
        • Medizinische Universitätsklinik Tübingen
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Medisch Centrum Alkmaar
      • Leiderdorp, Netherlands, 2353 GA
        • Rijnland Ziekenhuis
      • Maastricht, Netherlands
        • UMC Maastricht
  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Scientific Research Institute of Circulation Pathology
      • St-Petersburg, Russian Federation, 197341
        • Almazov Federal Heart, Blood & Endocrinolgoy Centre
  • Slovakia
      • Banska Bystrica, Slovakia, 974 01
        • SsUSCH Baska Bystrica
      • Bratislava, Slovakia, 833 48
        • NÚSCH Bratislava a.s.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Atrial Fibrillation Burden (AF Burden)
Time Frame: 46 hrs
46 hrs

Secondary Outcome Measures

Outcome Measure
Time Frame
AF episode detection accuracy and AF episode duration accuracy
Time Frame: 46 hrs
46 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic BRC

Investigators

  • Study Director: Guido H. Rieger, MD, Medtronic Bakken Research Center B.V.
  • Principal Investigator: Gerhard Hindricks, MD, PhD, Heart Center Leipzig - University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria

May 15, 2008

First Posted (Estimate)

May 20, 2008

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMD 446

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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