NCT00680927

Reveal® XT Performance Trial (XPECT)

Reveal® XT Performance Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Medtronic BRC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Risk of Cardiac Arrhythmias

Interventions

Type	Name	Description
OTHER	46 hrs Holter ECG recording	Maximum of 2 46 hrs external Holter ECG recordings are required.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-05-20
• Last updated: 2015-06-03

Locations

24 sites across 8 countries: Austria, Belgium, Canada, Czechia, Germany, Netherlands, Russia, Slovakia