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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

Tracking Information
First Submitted Date June 24, 2014
First Posted Date June 25, 2014
Last Update Posted Date January 7, 2016
Study Start Date July 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 24, 2014)
  • Planned corrective action [ Time Frame: 1 month ]
    Rate of detected anomalies triggering a planned corrective action
  • 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
  • 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)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Intracardiac Electrograms Transmitted by Home Monitoring for the Remote Follow-up of Pacemaker (PREMS)
Official Title Pacemaker Remote Electrogram Monitoring Study (PREMS)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patient implanted with a single or dual chamber pacemaker and with the Biotronik Home-Monitoring® system activated
Condition Bradycardia
Intervention Not Provided
Study Groups/Cohorts Pacemaker recipients
Patients implanted with a single or dual pacemaker and with Home-Monitoring system activated and periodic IEGM activated
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 6, 2016)
571
Original Estimated Enrollment
 (submitted: June 24, 2014)
562
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02174484
Other Study ID Numbers HS057
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biotronik SE & Co. KG
Study Sponsor Biotronik SE & Co. KG
Collaborators Not Provided
Investigators
Principal Investigator: Arnaud Lazarus, MD Clinique Ambroise Paré, Neuilly sur Seine, France
PRS Account Biotronik SE & Co. KG
Verification Date January 2016