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

Pacemaker Remote Electrogram Monitoring Study (PREMS)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02174484

Acronym

PREMS

Enrollment

571

Registered

2014-06-25

Start date

2014-07-31

Completion date

2015-12-31

Last updated

2016-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia

Keywords

Pacemaker, Remote monitoring, Remote follow-up, Home monitoring, Periodic IEGM, Intracardiac electrogram

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Added clinical value of periodic IEGM	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

Measure	Time frame	Description
Type of detected anomalies	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)
Planned corrective action	1 month	Rate of detected anomalies triggering a planned corrective action
Added clinical value of the remote follow-up	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
Capability of periodic IEGM to fulfil the guidelines requirements	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.

Countries

France

Outcome results