Clinical Trial: Virtual Clinic Pacemaker Follow-up
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: 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 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. 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.
Sponsor: Biotronik SE & Co. KG
Current Primary Outcome: Total work load for virtual clinic follow-up compared to standard follow-up (without Home Monitoring) [ Time Frame: 7 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Hospitalisation; Other serious adverse events; Quality of life; Total costs of therapy. [ Time Frame: 7 years ]
Original Secondary Outcome: Hospitalisation; Other serious adverse events; Quality of life (Health survey SF-36); Total costs of therapy. [ Time Frame: 7 years ]
Information By: Biotronik SE & Co. KG
Dates:
Date Received: May 16, 2007
Date Started: May 2007
Date Completion:
Last Updated: October 30, 2014
Last Verified: October 2014
