Virtual Clinic Pacemaker Follow-up

NCT00475124 | Terminated Phase 4

• 1 other identifier: HS036
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 6

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.

Conditions

Sick Sinus Syndrome; Heart Block; Bradycardia

Keywords

Pacemaker follow-up; Telecardiology; Home Monitoring

Outcome Measures

Primary Outcomes (1)

• Total work load for virtual clinic follow-up compared to standard follow-up (without Home Monitoring)

  7 years

Secondary Outcomes (1)

• Hospitalisation; Other serious adverse events; Quality of life; Total costs of therapy.

  7 years

Study Arms (2)

1

EXPERIMENTAL

Home Monitoring ON

Device: Home Monitoring of pacemaker

2

ACTIVE COMPARATOR

Home Monitoring OFF

Device: Home Monitoring of pacemaker deactivated

Interventions

Home Monitoring of pacemaker DEVICE

Daily Home Monitoring data transmission from the implanted pacemaker to Home Monitoring service center.

1

Home Monitoring of pacemaker deactivated DEVICE

No Home Monitoring data transmission.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for implantation of dual-chamber rate-adaptive pacemaker
• Stable medical situation
• Patient informed consent

You may not qualify if:

• Contra-indication for implantation of dual-chamber rate-adaptive pacemaker
• Persistent atrial fibrillation
• Replacement indication
• Participation in another clinical trial

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (6)

Barnet & Chase Farm Hospital

Barnet, EN5 3DJ, United Kingdom

Location

Basildon Hospital

Basildon, SS16 5NL, United Kingdom

Location

St. Peter's Hospital

Chertsey, KT16 0QA, United Kingdom

Location

Russels Hall Hospital

Dudley, DY1 2HQ, United Kingdom

Location

North Middlesex University Hospital

London, N18 1QX, United Kingdom

Location

Newcross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Sick Sinus Syndrome; Heart Block; Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Fluck, Dr.

  St. Peter's Hospital, Chertsey, UK

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: May 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 31, 2014

Record last verified: 2014-10

Locations

GB (6)