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

Study Overview
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Brief Summary
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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.

Official Title
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Pacemaker Remote Electrogram Monitoring Study (PREMS)

Conditions
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Bradycardia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pacemaker recipients<br>Patients implanted with a single or dual pacemaker and with Home-Monitoring system activated and periodic IEGM activated | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Added clinical value of periodic IEGM | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Planned corrective action | Rate of detected anomalies triggering a planned corrective action | 1 month | 
| Added clinical value of the remote follow-up | Rate of anomalies that can be identified based on remote data other than the periodic IEGM and comparison with the previous event notifications | 1 month | 
| Type of detected anomalies | 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) | 1 month | 
| Capability of periodic IEGM to fulfil the guidelines requirements | 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. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacemaker, Remote monitoring, Remote follow-up, Home monitoring, Periodic IEGM, Intracardiac electrogram