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Reveal® XT Performance Trial (XPECT)

NCT00680927 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2015-06-03

No results posted yet for this study

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.

Conditions

Interventions

OTHER

46 hrs Holter ECG recording

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

Sponsors & Collaborators

  • Medtronic BRC

    lead INDUSTRY

Principal Investigators

  • Guido H. Rieger, MD · Medtronic Bakken Research Center B.V.

  • Gerhard Hindricks, MD, PhD · Heart Center Leipzig - University Hospital

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Austria
  • Belgium
  • Canada
  • Czechia
  • Germany
  • Netherlands
  • Russia
  • Slovakia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00680927 on ClinicalTrials.gov