Assessment of Intracardiac Electrograms Transmitted by Home Monitoring for the Remote Follow-up of Pacemaker (PREMS) (PREMS)
|ClinicalTrials.gov Identifier: NCT02174484|
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : January 7, 2016
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||571 participants|
|Official Title:||Pacemaker Remote Electrogram Monitoring Study (PREMS)|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Patients implanted with a single or dual pacemaker and with Home-Monitoring system activated and periodic IEGM activated
- 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.
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.
- Planned corrective action [ Time Frame: 1 month ]Rate of detected anomalies triggering a planned corrective action
- 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
- 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174484
|Principal Investigator:||Arnaud Lazarus, MD||Clinique Ambroise Paré, Neuilly sur Seine, France|