Clinical trial NCT02174484: Assessment of Intracardiac Electrograms Transmitted by Home Monitoring for the Remote Follow-up of Pacemaker (PREMS)
Official title: Pacemaker Remote Electrogram Monitoring Study (PREMS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Keywords: Pacemaker
Remote monitoring
Remote follow-up
Home monitoring
Periodic IEGM
Intracardiac electrogram
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2014-06-25
Enrollment: 571
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient implanted with a single or dual chamber pacemaker and with the Biotronik Home-Monitoring® system activated

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.


Eligibility criteria: 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

Primary outcomes:
measure: Added clinical value of periodic IEGM
timeFrame: 1 month
Secondary outcomes:
measure: Planned corrective action
timeFrame: 1 month
measure: Added clinical value of the remote follow-up
timeFrame: 1 month
measure: Type of detected anomalies
timeFrame: 1 month
measure: Capability of periodic IEGM to fulfil the guidelines requirements
timeFrame: 1 month
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Clinique Axium
city: Angers
country: France
facility: Clinique de l'Anjou
city: Annecy
country: France
facility: CH d'Annecy
city: Annonay
country: France
facility: CH Annonay
city: Antibes
country: France
facility: CH d'Antibes
city: Aurillac
country: France
facility: CH d'Aurillac
city: Bastia
country: France
facility: CH de Bastia
city: Besancon
country: France
facility: Clinique Saint Vincent
city: Blois
country: France
facility: CH de Blois
city: Bordeaux
country: France
facility: Cabinet de Cardiologie
city: Bordeaux
country: France
facility: Polyclinique Nord Aquitaine
city: Bourgoin-Jallieu
country: France
facility: CH Pierre Oudot
city: Cannes
country: France
facility: CH des Broussailles
city: Castres
country: France
facility: CH de Castres
city: Cesson Sevigne
country: France
facility: Polyclinique Sevigné
city: Chambéry
country: France
facility: CH de Chambéry
city: Champigny sur Marne
country: France
facility: Hôpital Privé Paul d'Egine
city: Chartres
country: France
facility: CH de Chartres
city: Chatellerault
country: France
facility: Clinique Bon Secours
city: Cholet
country: France
facility: Polyclinique du Parc
city: Clermont-Ferrand
country: France
facility: Clinique des Dômes
city: Douarnenez
country: France
facility: CH de Douarnenez
city: Evry
country: France
facility: Clinique du Mousseau
city: Gueret
country: France
facility: Clinique de la Marche
city: Le Puy En Velay
country: France
facility: Cabinet de cardiologie
city: Longjumeau
country: France
facility: CHG de Longjumeau
city: Lyon
country: France
facility: CH St Luc St Joseph
city: Marseille
country: France
facility: Clinique Clairval
city: Montbrison
country: France
facility: CH Montbrison
city: Nevers
country: France
facility: CH de Nevers
city: Niort
country: France
facility: Cabinet Descartes
city: Niort
country: France
facility: CH de Niort
city: Provins
country: France
facility: CH Léon Binet
city: Rennes
country: France
facility: Polyclinique Saint Laurent
city: Roanne
country: France
facility: CH de Roanne
city: Rouen
country: France
facility: CHU Hôpital Charles Nicolle
city: Saint Georges de Didonne
country: France
facility: Clinique de Saint Georges de Didonnes
city: Saint Jean de Verge
country: France
facility: CH Val d'Ariège
city: Saint Malo
country: France
facility: CH de Saint Malo
city: Saint Martin d'Heres
country: France
facility: Clinique Belledonne
city: Thonon-Les-Bains
country: France
facility: Hôpitaux du Léman
city: Toulon
country: France
facility: HIA Saint Anne
city: Toulon
country: France
facility: Hôpital Sainte Musse CHI
city: Trappes
country: France
facility: HPOP
city: Valence
country: France
facility: CH de Valence
city: Valognes
country: France
facility: Cabinet de cardiologie
city: Versailles
country: France
facility: CH André Mignot
city: Vesoul
country: France
facility: CH Paul Morel
city: Villefranche Sur Saone
country: France
facility: CHG Villefranche
Study officials:
affiliation: Clinique Ambroise Paré, Neuilly sur Seine, France
name: Arnaud Lazarus, MD
role: PRINCIPAL_INVESTIGATOR
References: