Assessment of Intracardiac Electrograms Transmitted by Home Monitoring for the Remote Follow-up of Pacemaker (PREMS)
NCT ID: NCT02174484
Last Updated: 2016-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
571 participants
OBSERVATIONAL
2014-07-31
2015-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pacemaker recipients
Patients implanted with a single or dual pacemaker and with Home-Monitoring system activated and periodic IEGM activated
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient unable to handle the Cardio messenger correctly
* Participation in another clinical study
18 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Arnaud Lazarus, MD
Role: PRINCIPAL_INVESTIGATOR
Clinique Ambroise Paré, Neuilly sur Seine, France
Locations
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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
Besançon, , France
CH de Blois
Blois, , France
Cabinet de Cardiologie
Bordeaux, , France
Polyclinique Nord Aquitaine
Bordeaux, , France
CH Pierre Oudot
Bourgoin, , France
CH des Broussailles
Cannes, , France
CH de Castres
Castres, , France
Polyclinique Sevigné
Cesson-Sévigné, , France
CH de Chambéry
Chambéry, , France
Hôpital Privé Paul d'Egine
Champigny-sur-Marne, , France
CH de Chartres
Chartres, , France
Clinique Bon Secours
Châtellerault, , France
Polyclinique du Parc
Cholet, , France
Clinique des Dômes
Clermont-Ferrand, , France
CH de Douarnenez
Douarnenez, , France
Clinique du Mousseau
Évry, , France
Clinique de la Marche
Guéret, , France
Cabinet de cardiologie
Le Puy-en-Velay, , France
CHG de Longjumeau
Longjumeau, , France
CH St Luc St Joseph
Lyon, , France
Clinique Clairval
Marseille, , France
CH Montbrison
Montbrison, , France
CH de Nevers
Nevers, , France
Cabinet Descartes
Niort, , France
CH de Niort
Niort, , France
CH Léon Binet
Provins, , France
Polyclinique Saint Laurent
Rennes, , France
CH de Roanne
Roanne, , France
CHU Hôpital Charles Nicolle
Rouen, , France
CH Val d'Ariège
Saint Jean de Verge, , France
Clinique de Saint Georges de Didonnes
Saint-Georges-de-Didonne, , France
Clinique Belledonne
Saint-Martin-d'Hères, , France
CH de Saint Malo
St-Malo, , France
Hôpitaux du Léman
Thonon-les-Bains, , France
HIA Saint Anne
Toulon, , France
Hôpital Sainte Musse CHI
Toulon, , France
HPOP
Trappes, , France
CH de Valence
Valence, , France
Cabinet de cardiologie
Valognes, , France
CH André Mignot
Versailles, , France
CH Paul Morel
Vesoul, , France
CHG Villefranche
Villefranche-sur-Saône, , France
Countries
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Other Identifiers
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HS057
Identifier Type: -
Identifier Source: org_study_id
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