Reveal® XT Performance Trial (XPECT)

Phase 4

Completed

• Conditions: Atrial Fibrillation; Risk of Cardiac Arrhythmias

• Registration Number: NCT00680927
• Lead Sponsor: Medtronic BRC

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-20
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-01
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation Burden (AF Burden)	46 hrs

Secondary Outcome Measures

Name	Time	Method
AF episode detection accuracy and AF episode duration accuracy	46 hrs

Trial Locations

Locations (24)

Salzburger Landeskliniken; 🇦🇹 Salzburg, Austria

University Gasthuisberg; 🇧🇪 Leuven, Belgium

Nemocnice Na Homolce Hospital; 🇨🇿 Prague, Czech Republic

Victoria Cardiac Arrhythmia Trials Inc.; 🇨🇦 Victoria, Canada

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Universität Leipzig Herzzentrum; 🇩🇪 Leipzig, Germany

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Almazov Federal Heart, Blood & Endocrinolgoy Centre; 🇷🇺 St-Petersburg, Russian Federation

Rijnland Ziekenhuis; 🇳🇱 Leiderdorp, Netherlands

SsUSCH Baska Bystrica; 🇸🇰 Banska Bystrica, Slovakia

NUSCH Bratislava a.s.; 🇸🇰 Bratislava, Slovakia

Klinika Kardiologie IKEM; 🇨🇿 Prague, Czech Republic

Herzzentrum Bad Krozingen, Elektrophysiologie; 🇩🇪 Bad Krozingen, Germany

Medisch Centrum Alkmaar; 🇳🇱 Alkmaar, Netherlands

UMC Maastricht; 🇳🇱 Maastricht, Netherlands

Scientific Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation

Charité Campus Mitte; 🇩🇪 Berlin, Germany

LKH - Universitätskliniken; 🇦🇹 Innsbruck, Austria

Hopital Laval; 🇨🇦 Quebec, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, Canada

Facultni Nemocnice Brno; 🇨🇿 Brno, Czech Republic

A.ö. Krankenhaus der Elisabethinen Linz; 🇦🇹 Linz, Austria

Kerckhoff Klinik Forschungsgesellschaft; 🇩🇪 Bad Nauheim, Germany

Medizinische Universitätsklinik Tübingen; 🇩🇪 Tübingen, Germany