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Sponsored by: |
Biotronik GmbH & Co. KG |
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Information provided by: | Biotronik GmbH & Co. KG |
ClinicalTrials.gov Identifier: | NCT00475124 |
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 | Intervention | Phase |
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Sick Sinus Syndrome Heart Block Bradycardia |
Device: Home Monitoring of pacemaker Device: Home Monitoring of pacemaker deactivated |
Phase IV |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | VIRTUE: Virtual Clinic Pacemaker Follow-up |
Enrollment: | 123 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2015 |
Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Home Monitoring ON
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Device: Home Monitoring of pacemaker
Daily Home Monitoring data transmission from the implanted pacemaker to Home Monitoring service center.
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2: Active Comparator
Home Monitoring OFF
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Device: Home Monitoring of pacemaker deactivated
No Home Monitoring data transmission.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
St. Peter's Hospital | |
Chertsey, United Kingdom, KT16 0QA | |
Basildon Hospital | |
Basildon, United Kingdom, SS16 5NL | |
Newcross Hospital | |
Wolverhampton, United Kingdom, WV10 0QP | |
Barnet & Chase Farm Hospital | |
Barnet, United Kingdom, EN5 3DJ | |
North Middlesex University Hospital | |
London, United Kingdom, N18 1QX | |
Russels Hall Hospital | |
Dudley, United Kingdom, DY1 2HQ |
Study Chair: | David Fluck, Dr. | St. Peter's Hospital, Chertsey, UK |
Responsible Party: | Biotronik GmbH & Co. KG ( Petra Maier ) |
Study ID Numbers: | HS036 |
Study First Received: | May 16, 2007 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00475124 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Pacemaker follow-up Telecardiology Home Monitoring |
Heart Diseases Arrhythmia, Sinus Heart Block |
Bradycardia Sick Sinus Syndrome Arrhythmias, Cardiac |
Disease Pathologic Processes Syndrome Cardiovascular Diseases |