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

Biotronik

Status: Completed

Conditions: Bradycardia

Study type: Observational

Funder types: Industry

Identifiers

NCT02174484

HS057

Details and patient eligibility

About

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.

Enrollment: 571 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

571 participants in 1 patient group

Pacemaker recipients

Description:

Patients implanted with a single or dual pacemaker and with Home-Monitoring system activated and periodic IEGM activated