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

Bradycardia Clinical Trial

— PREMS  

Official title:

Pacemaker Remote Electrogram Monitoring Study (PREMS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174484
• Other study ID #: HS057
• Status: Completed
• Phase: N/A
• First received: June 24, 2014
• Last updated: January 6, 2016
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Conseil National de l'Ordre des MédecinsFrance: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 571
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bradycardia

Locations

Country	Name	City	State
France	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	Besancon
France	CH de Blois	Blois
France	Cabinet de Cardiologie	Bordeaux
France	Polyclinique Nord Aquitaine	Bordeaux
France	CH Pierre Oudot	Bourgoin-Jallieu
France	CH des Broussailles	Cannes
France	CH de Castres	Castres
France	Polyclinique Sevigné	Cesson Sevigne
France	CH de Chambéry	Chambéry
France	Hôpital Privé Paul d'Egine	Champigny sur Marne
France	CH de Chartres	Chartres
France	Clinique Bon Secours	Chatellerault
France	Polyclinique du Parc	Cholet
France	Clinique des Dômes	Clermont-Ferrand
France	CH de Douarnenez	Douarnenez
France	Clinique du Mousseau	Evry
France	Clinique de la Marche	Gueret
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	Clinique de Saint Georges de Didonnes	Saint Georges de Didonne
France	CH Val d'Ariège	Saint Jean de Verge
France	CH de Saint Malo	Saint Malo
France	Clinique Belledonne	Saint Martin d'Heres
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 Saone

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Planned corrective action	Rate of detected anomalies triggering a planned corrective action	1 month	Yes
Secondary	Added clinical value of the remote follow-up	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	Yes
Secondary	Type of detected anomalies	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	Yes
Secondary	Capability of periodic IEGM to fulfil the guidelines requirements	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	No