Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475124
Status:
TERMINATED
Last Update Posted:
2014-10-31
First Post:
2007-05-16
Brief Title:
Virtual Clinic Pacemaker Follow-up
Sponsor:
Biotronik SE Co KG
Organization:
Biotronik SE Co KG
Study Overview
Official Title:
VIRTUE Virtual Clinic Pacemaker Follow-up
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIRTUE
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 patients 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
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 patients 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 patients 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 patients expenses and patient travel and waiting time for visits to the pacer clinic as well as to additional cardiologists or internal medicine doctors 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
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 patients 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 patients expenses and patient travel and waiting time for visits to the pacer clinic as well as to additional cardiologists or internal medicine doctors 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None