Virtual Clinic Pacemaker Follow-up (VIRTUE)

VIRTUE: Virtual Clinic Pacemaker Follow-up

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.

Study Overview

• Status: Terminated
• Conditions: Heart Block; Bradycardia; Sick Sinus Syndrome
• Intervention / Treatment: Device: Home Monitoring of pacemaker; Device: Home Monitoring of pacemaker deactivated

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.

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Barnet, United Kingdom, EN5 3DJ
    • Barnet & Chase Farm Hospital
  • Basildon, United Kingdom, SS16 5NL
    • Basildon Hospital
  • Chertsey, United Kingdom, KT16 0QA
    • St. Peter's Hospital
  • Dudley, United Kingdom, DY1 2HQ
    • Russels Hall Hospital
  • London, United Kingdom, N18 1QX
    • North Middlesex University Hospital
  • Wolverhampton, United Kingdom, WV10 0QP
    • Newcross Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Home Monitoring ON	Device: Home Monitoring of pacemaker; Daily Home Monitoring data transmission from the implanted pacemaker to Home Monitoring service center.
Active Comparator: 2; Home Monitoring OFF	Device: Home Monitoring of pacemaker deactivated; No Home Monitoring data transmission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total work load for virtual clinic follow-up compared to standard follow-up (without Home Monitoring)	7 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospitalisation; Other serious adverse events; Quality of life; Total costs of therapy.	7 years

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Study Chair: David Fluck, Dr., St. Peter's Hospital, Chertsey, UK

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: May 16, 2007
• First Submitted That Met QC Criteria: May 16, 2007
• First Posted (Estimate): May 17, 2007

Study Record Updates

• Last Update Posted (Estimate): October 31, 2014
• Last Update Submitted That Met QC Criteria: October 30, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Home Monitoring; Pacemaker follow-up; Telecardiology
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Heart Block; Bradycardia; Sick Sinus Syndrome
• Other Study ID Numbers: HS036