Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174484
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

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.


Condition or disease
Bradycardia

Layout table for study information
Study Type : Observational
Actual Enrollment : 571 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pacemaker Remote Electrogram Monitoring Study (PREMS)
Study Start Date : July 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Group/Cohort
Pacemaker recipients
Patients implanted with a single or dual pacemaker and with Home-Monitoring system activated and periodic IEGM activated



Primary Outcome Measures :
  1. Added clinical value of periodic IEGM [ Time Frame: 1 month ]

    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.



Secondary Outcome Measures :
  1. Planned corrective action [ Time Frame: 1 month ]
    Rate of detected anomalies triggering a planned corrective action

  2. Added clinical value of the remote follow-up [ Time Frame: 1 month ]
    Rate of anomalies that can be identified based on remote data other than the periodic IEGM and comparison with the previous event notifications

  3. Type of detected anomalies [ Time Frame: 1 month ]
    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)

  4. Capability of periodic IEGM to fulfil the guidelines requirements [ Time Frame: 1 month ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient implanted with a single or dual chamber pacemaker and with the Biotronik Home-Monitoring® system activated
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174484


Locations
Show Show 49 study locations
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Layout table for investigator information
Principal Investigator: Arnaud Lazarus, MD Clinique Ambroise Paré, Neuilly sur Seine, France
Layout table for additonal information
Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT02174484    
Other Study ID Numbers: HS057
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016
Keywords provided by Biotronik SE & Co. KG:
Pacemaker
Remote monitoring
Remote follow-up
Home monitoring
Periodic IEGM
Intracardiac electrogram
Additional relevant MeSH terms:
Layout table for MeSH terms
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes