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Virtual Clinic Pacemaker Follow-up

NCT00475124 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2014-10-31

No results posted yet for this study

Summary

Patients with implanted pacemakers are currently seen by their cardiologists every 6-12 months. Shorter follow-up intervals are generally seen as excessive workload for the physician, with little benefit for the patient. Longer intervals are seen as too dangerous concerning device integrity and safety. This scheme still results in a large number of follow-up visits with little or no important changes in pacemaker therapy.

Our clinical trial investigates efficacy and safety of the Home Monitoring technology for increasing the flexibility in pacemaker follow-up. Home Monitoring technology allows automatic transmission via mobile phone links of relevant data from the implanted pacemaker to a service center. The patient's physician can access the data via a password-protected internet site. The regular Home Monitoring data analyses entirely replace clinical routine visits ("virtual clinic"). Follow-up visits are scheduled according to the results of the Home Monitoring data analyses.

The primary endpoint of the study is to compare the total workload for pacemaker patient care in the virtual clinic with that of standard follow-up scheme with regularly scheduled clinical visits.

Conditions

  • Sick Sinus Syndrome
  • Heart Block
  • Bradycardia

Interventions

DEVICE

Home Monitoring of pacemaker

Daily Home Monitoring data transmission from the implanted pacemaker to Home Monitoring service center.

DEVICE

Home Monitoring of pacemaker deactivated

No Home Monitoring data transmission.

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • David Fluck, Dr. · St. Peter's Hospital, Chertsey, UK

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United Kingdom

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 NCT00475124 on ClinicalTrials.gov