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Assessment of Intracardiac Electrograms Transmitted by Home Monitoring for the Remote Follow-up of Pacemaker (PREMS)

NCT02174484 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 571

Last updated 2016-01-07

No results posted yet for this study

Summary

The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm, sensing and capture, and thus to detect anomalies that may deserve a clinical action.

PREMS is a non-interventional, prospective, and multicenter study. The primary objective is to assess the added clinical value of periodic IEGMs, based on the rate of patients with a rhythm or sensing/pacing anomaly detected on the first IEGM transmitted by Home Monitoring (HM) and non detectable so obvious on the other parameter set offered for the remote follow-up.

Conditions

  • Bradycardia

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Arnaud Lazarus, MD · Clinique Ambroise Paré, Neuilly sur Seine, France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • France

Study Locations

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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 NCT02174484 on ClinicalTrials.gov