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Completed

NCT Number: NCT02174484

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

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.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Axium, Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient implanted with a single or dual chamber PM within the last 3 months
  • Home-Monitoring activated and functional
  • Periodic IEGM "ON" and programmed at 30 days intervals
  • Patient willing and able to comply with the protocol and who has provided written informed consent about HM
  • Patient whose medical situation is stable

Exclusion criteria

  • Age < 18 years
  • Patient unable to handle the Cardio messenger correctly
  • Participation in another clinical study

Treatment and study plan

Primary outcomes

  1. Added clinical value of periodic IEGM

    Time frame: 1 month

    The main objective of the study is to evaluate the added clinical value of periodic IEGMs for the remote follow-up of PM, compared to other HM data offered by the remote follow-up.

    Primary endpoint:

    Rate of patients with at least one rhythm or sensing/pacing anomaly detected on the periodic IEGM, and non detectable on the other HM data. The anomalies are defined as an arrhythmia (extrasystole, atrial fibrillation or flutter), loss of sensing, oversensing or loss of capture.

Secondary outcomes

  1. Planned corrective action

    Time frame: 1 month

    Rate of detected anomalies triggering a planned corrective action

  2. Added clinical value of the remote follow-up

    Time frame: 1 month

    Rate of anomalies that can be identified based on remote data other than the periodic IEGM and comparison with the previous event notifications

  3. Type of detected anomalies

    Time frame: 1 month

    The types of anomalies detected on the periodic IEGM or/and on the other HM data will be evaluated separately (arrhythmia, loss of capture, loss of sensing, oversensing)

  4. Capability of periodic IEGM to fulfil the guidelines requirements

    Time frame: 1 month

    The periodic IEGMs transmitted by HM are designed in accordance with ACC/AHA/HRS guidelines. Indeed, guidelines for a PM follow-up require to determine the current intrinsic rhythm, but also to check the appropriate sensing and capture. The periodic IEGM could remotely provide the same information than an in-office follow-up. So, the capability of periodic IEGM to fulfil the requirements for PM follow-up by ACC/AHA/HRS guidelines will be evaluated.

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Pacemaker Remote Electrogram Monitoring Study (PREMS)

Acronym: PREMS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2014
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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