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

Completed

• Conditions: Bradycardia

• Registration Number: NCT02174484
• Lead Sponsor: Biotronik SE & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Study Start: 2014-07
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 571

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Planned corrective action	1 month	Rate of detected anomalies triggering a planned corrective action
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)
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.

Trial Locations

Locations (48)

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; 🇫🇷 Besancon, France

CH de Blois; 🇫🇷 Blois, France

Cabinet de Cardiologie; 🇫🇷 Bordeaux, France

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