Virtual Clinic Pacemaker Follow-up
- Conditions
- Sick Sinus SyndromeHeart BlockBradycardia
- Interventions
- Device: Home Monitoring of pacemakerDevice: Home Monitoring of pacemaker deactivated
- Registration Number
- NCT00475124
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 123
- Indication for implantation of dual-chamber rate-adaptive pacemaker
- Stable medical situation
- Patient informed consent
- Contra-indication for implantation of dual-chamber rate-adaptive pacemaker
- Persistent atrial fibrillation
- Replacement indication
- Participation in another clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Home Monitoring of pacemaker Home Monitoring ON 2 Home Monitoring of pacemaker deactivated Home Monitoring OFF
- Primary Outcome Measures
Name Time Method Total work load for virtual clinic follow-up compared to standard follow-up (without Home Monitoring) 7 years
- Secondary Outcome Measures
Name Time Method Hospitalisation; Other serious adverse events; Quality of life; Total costs of therapy. 7 years
Trial Locations
- Locations (6)
St. Peter's Hospital
🇬🇧Chertsey, United Kingdom
Barnet & Chase Farm Hospital
🇬🇧Barnet, United Kingdom
Basildon Hospital
🇬🇧Basildon, United Kingdom
North Middlesex University Hospital
🇬🇧London, United Kingdom
Newcross Hospital
🇬🇧Wolverhampton, United Kingdom
Russels Hall Hospital
🇬🇧Dudley, United Kingdom