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Virtual Clinic Pacemaker Follow-up (VIRTUE)

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ClinicalTrials.gov Identifier: NCT00475124
Recruitment Status : Terminated (Redundant in-clinic visits increased the workload in virtual follow-up group. An interim analysis showed that the study would not support the primary hypothesis)
First Posted : May 17, 2007
Last Update Posted : October 31, 2014
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Tracking Information
First Submitted Date  ICMJE May 16, 2007
First Posted Date  ICMJE May 17, 2007
Last Update Posted Date October 31, 2014
Study Start Date  ICMJE May 2007
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2007)
Total work load for virtual clinic follow-up compared to standard follow-up (without Home Monitoring) [ Time Frame: 7 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00475124 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2007)
Hospitalisation; Other serious adverse events; Quality of life; Total costs of therapy. [ Time Frame: 7 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2007)
Hospitalisation; Other serious adverse events; Quality of life (Health survey SF-36); Total costs of therapy. [ Time Frame: 7 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Clinic Pacemaker Follow-up
Official Title  ICMJE VIRTUE: Virtual Clinic Pacemaker Follow-up
Brief 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.

Detailed Description

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. On the other hand, in some patients there are quicker changes in their cardiac situation and the need for subsequent adaptation of pacemaker programming, which cannot be detected and properly treated with standard follow-up scheme.

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.

For the primary endpoint, the total workload for pacemaker patient care in the virtual clinic is compared to that of a standard follow-up scheme with regular clinic visits. The total workload comprises the time for data analyses, clinical examinations, and other patient contacts.

Secondary endpoints investigate adverse events rate, quality of life, and total costs, as mirrored by direct patient's expenses, and patient travel and waiting time, for visits to the pacer clinic as well as to additional cardiologist's or internal medicine doctor's services.

Standard vs. virtual follow-up. For the standard follow-up group patients, routine follow-up visits are scheduled 1 month and 12 months after pre-discharge control, and then every 12 months. A follow-up at 6 months after discharge is optional. For the virtual clinic group patients, a routine follow-up visit is scheduled 1 month after pre-discharge control. The Home Monitoring data analyses have to be performed 12 months after discharge, and then every 12 months. If a 6-month follow-up is routinely done for the standard group in the clinic, a 6-month Home Monitoring data analysis has to be done as well. Event reports have to be analysed within 24 hours during working days.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Sick Sinus Syndrome
  • Heart Block
  • Bradycardia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: 1
    Home Monitoring ON
    Intervention: Device: Home Monitoring of pacemaker
  • Active Comparator: 2
    Home Monitoring OFF
    Intervention: Device: Home Monitoring of pacemaker deactivated
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  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 12, 2009)
123
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2007)
120
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Indication for implantation of dual-chamber rate-adaptive pacemaker
  • Stable medical situation
  • Patient informed consent

Exclusion Criteria:

  • Contra-indication for implantation of dual-chamber rate-adaptive pacemaker
  • Persistent atrial fibrillation
  • Replacement indication
  • Participation in another clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00475124
Other Study ID Numbers  ICMJE HS036
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biotronik SE & Co. KG
Study Sponsor  ICMJE Biotronik SE & Co. KG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: David Fluck, Dr. St. Peter's Hospital, Chertsey, UK
PRS Account Biotronik SE & Co. KG
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP