AzTrials
AzTrials

BradycardiaPREMSNCT02174484

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

An observational study of Bradycardia, run by Biotronik SE & Co. KG at 49 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bradycardia
How many people
571 participants
Where
49 sitesFrance
Study dates
Jul 2014to Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Age < 18 years
  • Patient unable to handle the Cardio messenger correctly
  • Participation in another clinical study

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

France49 sites

  • Clinique Axium

    Aix-en-Provence

  • Clinique de l'Anjou

    Angers, 49044

  • CH d'Annecy

    Annecy

  • CH Annonay

    Annonay

  • CH d'Antibes

    Antibes, 06606

  • CH d'Aurillac

    Aurillac

  • CH de Bastia

    Bastia

  • Clinique Saint Vincent

    Besançon

  • CH de Blois

    Blois

  • Cabinet de Cardiologie

    Bordeaux

  • Polyclinique Nord Aquitaine

    Bordeaux

  • CH Pierre Oudot

    Bourgoin

  • CH des Broussailles

    Cannes

  • CH de Castres

    Castres

  • Polyclinique Sevigné

    Cesson-Sévigné

  • CH de Chambéry

    Chambéry

  • Hôpital Privé Paul d'Egine

    Champigny-sur-Marne

  • CH de Chartres

    Chartres

  • Clinique Bon Secours

    Châtellerault

  • Polyclinique du Parc

    Cholet

  • Clinique des Dômes

    Clermont-Ferrand

  • CH de Douarnenez

    Douarnenez

  • Clinique du Mousseau

    Évry

  • Clinique de la Marche

    Guéret

  • Cabinet de cardiologie

    Le Puy-en-Velay

  • CHG de Longjumeau

    Longjumeau

  • CH St Luc St Joseph

    Lyon

  • Clinique Clairval

    Marseille

  • CH Montbrison

    Montbrison

  • CH de Nevers

    Nevers

  • Cabinet Descartes

    Niort

  • CH de Niort

    Niort

  • CH Léon Binet

    Provins

  • Polyclinique Saint Laurent

    Rennes

  • CH de Roanne

    Roanne

  • CHU Hôpital Charles Nicolle

    Rouen

  • CH Val d'Ariège

    Saint Jean de Verge

  • Clinique de Saint Georges de Didonnes

    Saint-Georges-de-Didonne

  • Clinique Belledonne

    Saint-Martin-d'Hères

  • CH de Saint Malo

    St-Malo

  • Hôpitaux du Léman

    Thonon-les-Bains

  • HIA Saint Anne

    Toulon

  • Hôpital Sainte Musse CHI

    Toulon

  • HPOP

    Trappes

  • CH de Valence

    Valence

  • Cabinet de cardiologie

    Valognes

  • CH André Mignot

    Versailles

  • CH Paul Morel

    Vesoul

  • CHG Villefranche

    Villefranche-sur-Saône

Other trials in France

About this study

Official title: 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.

Conditions
Bradycardia
Keywords
Pacemaker, Remote monitoring, Remote follow-up, Home monitoring, Periodic IEGM, Intracardiac electrogram
Medical subject headings
Bradycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02174484
Study groupRoleWhat they receive
Pacemaker recipientsPatients implanted with a single or dual pacemaker and with Home-Monitoring system activated and periodic IEGM activated

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 month

Secondary outcomes (4)

  1. Planned corrective action

    Rate of detected anomalies triggering a planned corrective action

    Measured: 1 month

  2. 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

    Measured: 1 month

  3. 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)

    Measured: 1 month

  4. 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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
571 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02174484
Sponsor's protocol ID
HS057
Acronym
PREMS
Status last verified
Jan 2016
First submitted
24 Jun 2014
Last updated
7 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Bradycardia, run by Biotronik SE & Co. KG at 49 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Added clinical value of periodic IEGM (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02174484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in