Reveal® XT Performance Trial (XPECT) - Full Text View

Sponsored by:	Medtronic BRC
Information provided by:	Medtronic BRC
ClinicalTrials.gov Identifier:	NCT00680927

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation Risk of Cardiac Arrhythmias	Other: 46 hrs Holter ECG recording	Phase IV

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Reveal® XT Performance Trial

Further study details as provided by Medtronic BRC:

Primary Outcome Measures:

Atrial Fibrillation Burden (AF Burden) [ Time Frame: 46 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AF episode detection accuracy and AF episode duration accuracy [ Time Frame: 46 hrs ] [ Designated as safety issue: No ]

Enrollment:	247
Study Start Date:	September 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680927

Locations

Austria
A.ö. Krankenhaus der Elisabethinen Linz
Linz, Austria, 4010
Salzburger Landeskliniken
Salzburg, Austria, A-5020
Belgium
University Gasthuisberg
Leuven, Belgium, B-3000
Czech Republic
Nemocnice Na Homolce Hospital
Prague, Czech Republic, 150 30
Klinika Kardiologie IKEM
Prague, Czech Republic, CZ 140-21
Facultni Nemocnice Brno
Brno, Czech Republic, CZ-625 00
Germany
Herzzentrum Bad Krozingen, Elektrophysiologie
Bad Krozingen, Germany, D-79189
Universität Leipzig Herzzentrum
Leipzig, Germany
Medizinische Universitätsklinik Tübingen
Tübingen, Germany, D-72076
Asklepios Klinik St. Georg
Hamburg, Germany, D-20099
Charité Campus Mitte
Berlin, Germany, D-10117
Kerckhoff Klinik Forschungsgesellschaft
Bad Nauheim, Germany, D-61231
Universitätsklinikum Bonn
Bonn, Germany, D-53105
Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands, 1815 JD
Rijnland Ziekenhuis
Leiderdorp, Netherlands, 2353 GA
UMC Maastricht
Maastricht, Netherlands
Slovakia
SsUSCH Baska Bystrica
Banska Bystrica, Slovakia, 974 01
NUSCH Bratislava a.s.
Bratislava, Slovakia, 833 48

Sponsors and Collaborators

Medtronic BRC

Investigators

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

More Information

No publications provided

Responsible Party:	Medtronic Bakken Research Center BV ( Medtronic Bakken Research Center BV )
Study ID Numbers:	CMD 446
Study First Received:	May 15, 2008
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00680927 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Slovakia: State Institute for Drug Control; Czech Republic: State Institute for Drug Control

Keywords provided by Medtronic BRC:

Atrial Fibrillation
Risk of cardiac arrhythmias
Loop recorder

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009