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Evaluate the Benefits of Pacemaker Follow-Up With Home-Monitoring

NCT00989326 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 543

Last updated 2010-06-24

No results posted yet for this study

Summary

The study investigates whether home monitoring follow-up of Pace-Maker patients is as efficient as conventional method in terms of Significant Serious Adverse Event (SSAE).

Conditions

  • Pacemaker, Artificial
  • Bradycardia

Interventions

OTHER

Home Monitoring

Both patient groups are followed for 18 months and will be followed with Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    collaborator INDUSTRY

  • Biotronik France

    lead INDUSTRY

Principal Investigators

  • Philippe P MABO, Pr, Dr · CHU Pontchaillou de Rennes

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00989326 on ClinicalTrials.gov