Trials / Completed
CompletedNCT02174484
Assessment of Intracardiac Electrograms Transmitted by Home Monitoring for the Remote Follow-up of Pacemaker (PREMS)
Pacemaker Remote Electrogram Monitoring Study (PREMS)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 571 (actual)
- Sponsor
- Biotronik SE & Co. KG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2014-06-25
- Last updated
- 2016-01-07
Locations
49 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02174484. Inclusion in this directory is not an endorsement.