Assessment of Intracardiac Electrograms Transmitted by Home Monitoring for the Remote Follow-up of Pacemaker (PREMS)
PREMS
Pacemaker Remote Electrogram Monitoring Study (PREMS)
1 other identifier
observational
571
1 country
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 7, 2016
January 1, 2016
1.4 years
June 24, 2014
January 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Added clinical value of periodic IEGM
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 Outcomes (4)
Planned corrective action
1 month
Added clinical value of the remote follow-up
1 month
Type of detected anomalies
1 month
Capability of periodic IEGM to fulfil the guidelines requirements
1 month
Study Arms (1)
Pacemaker recipients
Patients implanted with a single or dual pacemaker and with Home-Monitoring system activated and periodic IEGM activated
Eligibility Criteria
Patient implanted with a single or dual chamber pacemaker and with the Biotronik Home-Monitoring® system activated
You may qualify if:
- 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
You may not qualify if:
- Age \< 18 years
- Patient unable to handle the Cardio messenger correctly
- Participation in another clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Clinique Axium
Aix-en-Provence, France
Clinique de l'Anjou
Angers, 49044, France
CH d'Annecy
Annecy, France
CH Annonay
Annonay, France
CH d'Antibes
Antibes, 06606, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arnaud Lazarus, MD
Clinique Ambroise Paré, Neuilly sur Seine, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2014
First Posted
June 25, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 7, 2016
Record last verified: 2016-01