Virtual Clinic Pacemaker Follow-up

Bradycardia Clinical Trial

— VIRTUE  

Official title:

VIRTUE: Virtual Clinic Pacemaker Follow-up

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00475124
• Other study ID #: HS036
• Status: Terminated
• Phase: Phase 4
• First received: May 16, 2007
• Last updated: October 30, 2014
• Start date: May 2007
• Est. completion date: September 2012

Study information

• Verified date: October 2014
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 123
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bradycardia
• Heart Block
• Sick Sinus Syndrome

Intervention

Device:
• Home Monitoring of pacemaker
Daily Home Monitoring data transmission from the implanted pacemaker to Home Monitoring service center.
• Home Monitoring of pacemaker deactivated
No Home Monitoring data transmission.

Locations

Country	Name	City	State
United Kingdom	Barnet & Chase Farm Hospital	Barnet
United Kingdom	Basildon Hospital	Basildon
United Kingdom	St. Peter's Hospital	Chertsey
United Kingdom	Russels Hall Hospital	Dudley
United Kingdom	North Middlesex University Hospital	London
United Kingdom	Newcross Hospital	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total work load for virtual clinic follow-up compared to standard follow-up (without Home Monitoring)		7 years	No
Secondary	Hospitalisation; Other serious adverse events; Quality of life; Total costs of therapy.		7 years	No