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

Biotronik SE & Co. KG571 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

571

Conditions

Bradycardia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (49)

Clinique Axium

Aix-en-Provence, France

Clinique de l'Anjou

Angers, France

CH d'Annecy

Annecy, France

CH Annonay

Annonay, France

CH d'Antibes

Antibes, France

CH d'Aurillac

Aurillac, France

CH de Bastia

Bastia, France

Clinique Saint Vincent

Besançon, France

CH de Blois

Blois, France

Cabinet de Cardiologie

Bordeaux, France

...and 39 more locations

Outcomes

Primary Outcomes

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.

Time frame: 1 month

Secondary Outcomes

Planned corrective action

Rate of detected anomalies triggering a planned corrective action

Time frame: 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

Time frame: 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)

Time frame: 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.

Time frame: 1 month