Sick Sinus SyndromePhase 4VIRTUENCT00475124
Virtual Clinic Pacemaker Follow-up
A Phase 4 study testing Home Monitoring of pacemaker and Home Monitoring of pacemaker deactivated in people with Sick Sinus Syndrome and Heart Block, run by Biotronik SE & Co. KG at 6 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sick Sinus Syndrome, Heart Block, Bradycardia
- What is being tested?
- Home Monitoring of pacemaker and Home Monitoring of pacemaker deactivated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- May 2007to Sep 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for implantation of dual-chamber rate-adaptive pacemaker
- Stable medical situation
- Patient informed consent
Who cannot join
- Contra-indication for implantation of dual-chamber rate-adaptive pacemaker
- Persistent atrial fibrillation
- Replacement indication
- Participation in another clinical trial
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Barnet & Chase Farm Hospital
Barnet, EN5 3DJ
Basildon Hospital
Basildon, SS16 5NL
St. Peter's Hospital
Chertsey, KT16 0QA
Russels Hall Hospital
Dudley, DY1 2HQ
North Middlesex University Hospital
London, N18 1QX
Newcross Hospital
Wolverhampton, WV10 0QP
About this study
Official title: 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.
Read the 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.
- Conditions
- Sick Sinus Syndrome, Heart Block, Bradycardia
- Being tested
- Home Monitoring of pacemaker, Home Monitoring of pacemaker deactivated
- Keywords
- Pacemaker follow-up, Telecardiology, Home Monitoring
- Medical subject headings
- Sick Sinus Syndrome, Heart Block, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Monitoring of pacemakerDevice
Daily Home Monitoring data transmission from the implanted pacemaker to Home Monitoring service center.
Home Monitoring of pacemaker deactivatedDevice
No Home Monitoring data transmission.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Home Monitoring ON Receives: Device: Home Monitoring of pacemaker |
| 2 | Active comparator | Home Monitoring OFF Receives: Device: Home Monitoring of pacemaker deactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total work load for virtual clinic follow-up compared to standard follow-up (without Home Monitoring)
Measured: 7 years
Secondary outcomes (1)
Hospitalisation; Other serious adverse events; Quality of life; Total costs of therapy.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startMay 2007
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sick Sinus SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Fluck, Dr., Study chair, St. Peter's Hospital, Chertsey, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475124
- Sponsor's protocol ID
- HS036
- Acronym
- VIRTUE
- Status last verified
- Oct 2014
- First submitted
- 16 May 2007
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIRTUE: Virtual Clinic Pacemaker Follow-up
- ClinicalTrials.gov ID
- NCT00475124
- Acronym / sponsor ID
- VIRTUE / HS036
- Conditions
- Sick Sinus Syndrome, Heart Block, Bradycardia
- Keywords
- Pacemaker follow-up, Telecardiology, Home Monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 17 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Home Monitoring of pacemakerHome Monitoring ON |
| 2 | Active comparator | Device: Home Monitoring of pacemaker deactivatedHome Monitoring OFF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for implantation of dual-chamber rate-adaptive pacemaker
- Stable medical situation
- Patient informed consent
Key exclusion criteria (4 listed)
- Contra-indication for implantation of dual-chamber rate-adaptive pacemaker
- Persistent atrial fibrillation
- Replacement indication
- Participation in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Monitoring of pacemakerDaily Home Monitoring data transmission from the implanted pacemaker to Home Monitoring service center. | Device | 1 |
| Home Monitoring of pacemaker deactivatedNo Home Monitoring data transmission. | Device | 2 |
Primary outcome
Total work load for virtual clinic follow-up compared to standard follow-up (without Home Monitoring)
Time frame: 7 years
1 secondary outcome
Hospitalisation; Other serious adverse events; Quality of life; Total costs of therapy.
Time frame: 7 years
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Fluck, Dr. study chair
St. Peter's Hospital, Chertsey, UK
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Home Monitoring of pacemaker and Home Monitoring of pacemaker deactivated in people with Sick Sinus Syndrome and Heart Block, run by Biotronik SE & Co. KG at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total work load for virtual clinic follow-up compared to standard follow-up (without Home Monitoring) (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.