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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

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.


Condition or disease Intervention/treatment Phase
Sick Sinus Syndrome Heart Block Bradycardia Device: Home Monitoring of pacemaker Device: Home Monitoring of pacemaker deactivated Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: VIRTUE: Virtual Clinic Pacemaker Follow-up
Study Start Date : May 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Home Monitoring ON
Device: Home Monitoring of pacemaker
Daily Home Monitoring data transmission from the implanted pacemaker to Home Monitoring service center.

Active Comparator: 2
Home Monitoring OFF
Device: Home Monitoring of pacemaker deactivated
No Home Monitoring data transmission.




Primary Outcome Measures :
  1. Total work load for virtual clinic follow-up compared to standard follow-up (without Home Monitoring) [ Time Frame: 7 years ]

Secondary Outcome Measures :
  1. Hospitalisation; Other serious adverse events; Quality of life; Total costs of therapy. [ Time Frame: 7 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00475124


Locations
United Kingdom
Barnet & Chase Farm Hospital
Barnet, United Kingdom, EN5 3DJ
Basildon Hospital
Basildon, United Kingdom, SS16 5NL
St. Peter's Hospital
Chertsey, United Kingdom, KT16 0QA
Russels Hall Hospital
Dudley, United Kingdom, DY1 2HQ
North Middlesex University Hospital
London, United Kingdom, N18 1QX
Newcross Hospital
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Study Chair: David Fluck, Dr. St. Peter's Hospital, Chertsey, UK

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00475124     History of Changes
Other Study ID Numbers: HS036
First Posted: May 17, 2007    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014

Keywords provided by Biotronik SE & Co. KG:
Pacemaker follow-up
Telecardiology
Home Monitoring

Additional relevant MeSH terms:
Bradycardia
Sick Sinus Syndrome
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus