Reveal® XT Performance Trial (XPECT)

Sponsor

Medtronic BRC (Industry)

Overall Status

Completed

CT.gov ID

NCT00680927

Collaborator

(none)

247

Enrollment

Locations

Duration (Months)

10.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Risk of Cardiac Arrhythmias	Other: 46 hrs Holter ECG recording	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

247 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

Reveal® XT Performance Trial

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Outcome Measures

Primary Outcome Measures

Atrial Fibrillation Burden (AF Burden) [46 hrs]

Secondary Outcome Measures

AF episode detection accuracy and AF episode duration accuracy [46 hrs]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

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

Locations

	Site	City	Country	Postal Code
1	LKH - Universitätskliniken	Innsbruck	Austria	A-6020
2	A.ö. Krankenhaus der Elisabethinen Linz	Linz	Austria	4010
3	Salzburger Landeskliniken	Salzburg	Austria	A-5020
4	University Gasthuisberg	Leuven	Belgium	B-3000
5	Hopital Laval	Quebec	Canada	G1V 4G5
6	St. Paul's Hospital	Vancouver	Canada	V6Z 1Y6
7	Victoria Cardiac Arrhythmia Trials Inc.	Victoria	Canada	V8R 4R2
8	Facultni Nemocnice Brno	Brno	Czech Republic	CZ-625 00
9	Nemocnice Na Homolce Hospital	Prague	Czech Republic	150 30
10	Klinika Kardiologie IKEM	Prague	Czech Republic	CZ 140-21
11	Herzzentrum Bad Krozingen, Elektrophysiologie	Bad Krozingen	Germany	D-79189
12	Kerckhoff Klinik Forschungsgesellschaft	Bad Nauheim	Germany	D-61231
13	Charité Campus Mitte	Berlin	Germany	D-10117
14	Universitätsklinikum Bonn	Bonn	Germany	D-53105
15	Asklepios Klinik St. Georg	Hamburg	Germany	D-20099
16	Universität Leipzig Herzzentrum	Leipzig	Germany
17	Medizinische Universitätsklinik Tübingen	Tübingen	Germany	D-72076
18	Medisch Centrum Alkmaar	Alkmaar	Netherlands	1815 JD
19	Rijnland Ziekenhuis	Leiderdorp	Netherlands	2353 GA
20	UMC Maastricht	Maastricht	Netherlands
21	Scientific Research Institute of Circulation Pathology	Novosibirsk	Russian Federation	630055
22	Almazov Federal Heart, Blood & Endocrinolgoy Centre	St-Petersburg	Russian Federation	197341
23	SsUSCH Baska Bystrica	Banska Bystrica	Slovakia	974 01
24	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, Heart Center Leipzig - University Hospital