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

January 6, 2016 updated by: Biotronik SE & Co. KG

Pacemaker Remote Electrogram Monitoring Study (PREMS)

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

571

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix en Provence, France
        • Clinique Axium
      • Angers, France, 49044
        • Clinique de l'Anjou
      • Annecy, France
        • CH d'Annecy
      • Annonay, France
        • Ch Annonay
      • Antibes, France, 06606
        • CH d'Antibes
      • Aurillac, France
        • CH d'Aurillac
      • Bastia, France
        • CH de Bastia
      • Besancon, France
        • Clinique Saint Vincent
      • Blois, France
        • CH de Blois
      • Bordeaux, France
        • Polyclinique Nord Aquitaine
      • Bordeaux, France
        • Cabinet de cardiologie
      • Bourgoin-Jallieu, France
        • CH Pierre Oudot
      • Cannes, France
        • CH des Broussailles
      • Castres, France
        • CH de Castres
      • Cesson Sevigne, France
        • Polyclinique Sevigné
      • Chambéry, France
        • CH de Chambery
      • Champigny sur Marne, France
        • Hopital Prive Paul d'Egine
      • Chartres, France
        • CH de Chartres
      • Chatellerault, France
        • Clinique Bon Secours
      • Cholet, France
        • Polyclinique du Parc
      • Clermont-Ferrand, France
        • Clinique Des Dômes
      • Douarnenez, France
        • CH de Douarnenez
      • Evry, France
        • Clinique Du Mousseau
      • Gueret, France
        • Clinique de la Marche
      • Le Puy En Velay, France
        • Cabinet de cardiologie
      • Longjumeau, France
        • CHG de Longjumeau
      • Lyon, France
        • CH St Luc St Joseph
      • Marseille, France
        • Clinique Clairval
      • Montbrison, France
        • CH Montbrison
      • Nevers, France
        • CH de Nevers
      • Niort, France
        • CH de Niort
      • Niort, France
        • Cabinet Descartes
      • Provins, France
        • CH Leon Binet
      • Rennes, France
        • Polyclinique Saint Laurent
      • Roanne, France
        • CH de Roanne
      • Rouen, France
        • CHU Hôpital Charles Nicolle
      • Saint Georges de Didonne, France
        • Clinique de Saint Georges de Didonnes
      • Saint Jean de Verge, France
        • CH Val d'Ariège
      • Saint Malo, France
        • CH de Saint Malo
      • Saint Martin d'Heres, France
        • Clinique Belledonne
      • Thonon-Les-Bains, France
        • Hôpitaux du Léman
      • Toulon, France
        • HIA Saint Anne
      • Toulon, France
        • Hôpital Sainte Musse CHI
      • Trappes, France
        • HPOP
      • Valence, France
        • CH de Valence
      • Valognes, France
        • Cabinet de cardiologie
      • Versailles, France
        • Ch Andre Mignot
      • Vesoul, France
        • CH Paul Morel
      • Villefranche Sur Saone, France
        • CHG Villefranche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient implanted with a single or dual chamber pacemaker and with the Biotronik Home-Monitoring® system activated

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pacemaker recipients
Patients implanted with a single or dual pacemaker and with Home-Monitoring system activated and periodic IEGM activated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Planned corrective action
Time Frame: 1 month
Rate of detected anomalies triggering a planned corrective action
1 month
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
1 month
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)
1 month
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Arnaud Lazarus, MD, Clinique Ambroise Paré, Neuilly sur Seine, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

January 7, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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