Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT00680927
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2008-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reveal® XT Performance Trial (XPECT)
Sponsor:
Medtronic BRC
Organization:
Study Overview
Official Title:
Reveal® XT Performance Trial
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: