Single or Dual Chamber Pacemaker ImplantationTELEPACENCT04148703
Cost-utility Analysis of the Follow-up of Exclusive Telemedicine Pacemakers, Compared to Conventional Pacemakers
A study testing Follow up post Pacemaker implantation in office and Follow up post Pacemaker implantation by home monitoring in people with Single or Dual Chamber Pacemaker Implantation and Home Monitoring Follow-up, run by Nantes University Hospital at 1 site in France.
Trial summary
TELEPACE is an economic evaluation that aims to determine the probability at which Home Monitoring without physical examinations, could be cost effective, compared to the conventional treatment by face to face consultations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Single or Dual Chamber Pacemaker Implantation, Home Monitoring Follow-up
- What is being tested?
- Follow up post Pacemaker implantation in office and Follow up post Pacemaker implantation by home monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2019to 5 May 2025
- Phase
- Interventional
- 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
- Single or dual chamber pacemaker implantation patients
- patients agree to be enrolled in the study and followed during 4 years
- patients have insurance coverage
Who cannot join
- Minor patients
- personn with disability
- pregnant women
- patient with life expectancy of less than 4 years
Trial locations and contacts
1 site in 1 country.
About this study
TELEPACE is an economic evaluation that aims to determine the probability at which Home Monitoring without physical examinations, could be cost effective, compared to the conventional treatment by face to face consultations. Patient will be randomized in a control group followed according to the current guidelines and and active group exclusively followed by remote monitoring. The study will end after a 4 year follow-up.
Read the detailed description
Professional practice guidelines recommend that pacemakers be followed with at least one to two in-office follow-ups per year, which is both a public health issue (the average time to get a consultation with a cardiologist being 42 days) but also an economic issue considering the number of patients implanted (Brignole EHJ 2013). Remote monitoring of pacemakers could allow an optimization of the long-term follow-up of pacemaker recipients in hospitals.
Compared to CRT and ICD, few studies have highlighted the economic advantage of remote monitoring with PM.
COMPAS study (Eur Heart J. 2012) demonstrated that remote monitoring is a safe alternative to conventional care over a 2 year-follow-up. This study also demonstrated that long-term remote monitoring of pacemakers decreased the number of ambulatory visits and enabled the early detection of important clinical and device-related adverse events.
As the study shows data up to 18 months, this is not sufficient to define the benefit of telecardiology in this population of patients.
SETAM study (Pacing Clin Electrophysiol 2017) demonstrated the benefit of remote monitoring showing an earlier diagnosis and management of atrial arrhythmias and a subsequently reduction of atrial fibrillation (AF) burden. The incidence and prevalence of AF is expected to increase with time, resulting in significant societal and economic impact.
Neither COMPAS nor SETAM were designed as economic evaluations
TELEPACE study proposes the first economic evaluation of an exclusive follow-up by Home-Monitoring of patients implanted with pacemaker for a period of 4 years.
All patients will be implanted with a single or dual chamber pacemaker according the implantation guidelines. Patients enrolled will be then randomized to a control group or an active group:
- The patients randomized in the control group will be followed accordingto the guidelines; i.e. with an in-office follow-up at 30 days post-implantation and after followed with in-office follow-ups according toclinical practice.
- Active group: in-office follow-up at 30 days post-implantation and after by remote monitoring (daily) without scheduled in-office follow-up during the study period (48 months). A remote FU will be planned every 9 months.
Consequently, compared to the guidelines, the patients in the active group will be followed according to the guidelines; except for the in-office follow-ups annually.
By collecting real costs directly on health insurance reimbursement bases (SNIIRAM), this study will define the medico-economic benefit of remote monitoring of pacemakers.
A cost-utility analysis is needed to address the question. The use of QALYs is not intended to demonstrate a difference in clinical efficacy but to ensure that efficacy and costs are studied simultaneously which is required in order to avoid risk inflation when differences in efficacy and costs are studied sequentially.
If there is no significant differences in QALYs (as expected) but there are savings in terms of HSR then the cost-utility ratio will allow to estimate a "net benefit criterion" (NBC) that translates QALYs into money as follows: NBC = WTP.(differences in QALYs) - (differences in costs) where WTP represents the (societal) willingness to pay a QALY.
If there is no differences in QALYs the NBC will then reduce to a cost-minimisation calculus (WTP.(diff QALYs) = 0).
Cost-minimisation alone can only be used (HAS regards it as a sub-category of cost-effectiveness analysis whose use has to be duly justified) provided that there is strong evidence of equivalence in terms of clinical efficacy. If this is not the case, a cost-utility analysis will be more relevant as it will test simultaneously for both differences in efficacy and in costs.
Moreover, the study will confrim the safety of telecardiology and evaluate patients' individual preferences for the different management strategies.
- Being tested
- Follow up post Pacemaker implantation in office, Follow up post Pacemaker implantation by home monitoring
- Keywords
- Pacemaker, home monitoring, remote monitoring, ecocomic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up post Pacemaker implantation in officeOther
All patients will be implanted with a single or dual chamber pacemaker according the implantation guidelines and will be followed by in-office follow-up
Follow up post Pacemaker implantation by home monitoringOther
All patients will be implanted with a single or dual chamber pacemaker according the implantation guidelines and will be followed by home monitoring
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | in-office follow-up at 30 days post-implantation and after by remote monitoring (daily) without scheduled in-office follow-up during the study period (48 months). A remote FU will be planned every 9 months. Receives: Other: Follow up post Pacemaker implantation by home monitoring |
| Control group | Active comparator | The patients randomized in the control group will be followed accordingto the guidelines; i.e. with an in-office follow-up at 30 days post-implantation and after followed with in-office follow-ups according to clinical practice. Receives: Other: Follow up post Pacemaker implantation in office |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICER (incremental cost effectivness ratio)
cost and medical consumtion collected with the French insurance care database
Measured: 4 years
QALY
Quality Adjusted Life Years estimated by EQ5D-5L
Measured: 4 years
Secondary outcomes (2)
Safety of home monitoring
time limit compensation claim (delay between the diagnosis and the therapy)
Measured: 4 years
Safety of home monitoring
combined criteria (death, stroke, heart failure, arrhythmia, pacemeker dysfunction, infection, hospitalization)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start4 Nov 2019
- Primary completion5 May 2025 (estimated)
- Study completion5 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single or Dual Chamber Pacemaker ImplantationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tours University Hospital, University Hospital, Marseille, Rennes University Hospital, University Hospital, Toulouse, University Hospital, Clermont-Ferrand, University Hospital, Angers, University Hospital, Lille, University Hospital, Strasbourg, France, University Hospital, Rouen, University Hospital, Montpellier, University Hospital, Brest, Pau University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148703
- Sponsor's protocol ID
- RC18_0431
- Acronym
- TELEPACE
- Status last verified
- May 2023
- First submitted
- 24 Oct 2019
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-utility Analysis of the Follow-up of Exclusive Telemedicine Pacemakers, Compared to Conventional Pacemakers
- ClinicalTrials.gov ID
- NCT04148703
- Acronym / sponsor ID
- TELEPACE / RC18_0431
- Keywords
- Pacemaker, home monitoring, remote monitoring, ecocomic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Tours University Hospital, University Hospital, Marseille, Rennes University Hospital, University Hospital, Toulouse, University Hospital, Clermont-Ferrand, University Hospital, Angers, University Hospital, Lille, University Hospital, Strasbourg, France, University Hospital, Rouen, University Hospital, Montpellier, University Hospital, Brest, Pau University Hospital
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 5 May 2025 (estimated)
- Study completion
- 5 May 2025 (estimated)
- First posted
- 1 Nov 2019 (actual)
- 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.
TELEPACE is an economic evaluation that aims to determine the probability at which Home Monitoring without physical examinations, could be cost effective, compared to the conventional treatment by face to face consultations. Patient will be randomized in a control group followed according to the current guidelines and and active group exclusively followed by remote monitoring. The study will end after a 4 year follow-up.
Detailed description
Professional practice guidelines recommend that pacemakers be followed with at least one to two in-office follow-ups per year, which is both a public health issue (the average time to get a consultation with a cardiologist being 42 days) but also an economic issue considering the number of patients implanted (Brignole EHJ 2013). Remote monitoring of pacemakers could allow an optimization of the long-term follow-up of pacemaker recipients in hospitals.
Compared to CRT and ICD, few studies have highlighted the economic advantage of remote monitoring with PM.
COMPAS study (Eur Heart J. 2012) demonstrated that remote monitoring is a safe alternative to conventional care over a 2 year-follow-up. This study also demonstrated that long-term remote monitoring of pacemakers decreased the number of ambulatory visits and enabled the early detection of important clinical and device-related adverse events.
As the study shows data up to 18 months, this is not sufficient to define the benefit of telecardiology in this population of patients.
SETAM study (Pacing Clin Electrophysiol 2017) demonstrated the benefit of remote monitoring showing an earlier diagnosis and management of atrial arrhythmias and a subsequently reduction of atrial fibrillation (AF) burden. The incidence and prevalence of AF is expected to increase with time, resulting in significant societal and economic impact.
Neither COMPAS nor SETAM were designed as economic evaluations
TELEPACE study proposes the first economic evaluation of an exclusive follow-up by Home-Monitoring of patients implanted with pacemaker for a period of 4 years.
All patients will be implanted with a single or dual chamber pacemaker according the implantation guidelines. Patients enrolled will be then randomized to a control group or an active group:
- The patients randomized in the control group will be followed accordingto the guidelines; i.e. with an in-office follow-up at 30 days post-implantation and after followed with in-office follow-ups according toclinical practice.
- Active group: in-office follow-up at 30 days post-implantation and after by remote monitoring (daily) without scheduled in-office follow-up during the study period (48 months). A remote FU will be planned every 9 months.
Consequently, compared to the guidelines, the patients in the active group will be followed according to the guidelines; except for the in-office follow-ups annually.
By collecting real costs directly on health insurance reimbursement bases (SNIIRAM), this study will define the medico-economic benefit of remote monitoring of pacemakers.
A cost-utility analysis is needed to address the question. The use of QALYs is not intended to demonstrate a difference in clinical efficacy but to ensure that efficacy and costs are studied simultaneously which is required in order to avoid risk inflation when differences in efficacy and costs are studied sequentially.
If there is no significant differences in QALYs (as expected) but there are savings in terms of HSR then the cost-utility ratio will allow to estimate a "net benefit criterion" (NBC) that translates QALYs into money as follows: NBC = WTP.(differences in QALYs) - (differences in costs) where WTP represents the (societal) willingness to pay a QALY.
If there is no differences in QALYs the NBC will then reduce to a cost-minimisation calculus (WTP.(diff QALYs) = 0).
Cost-minimisation alone can only be used (HAS regards it as a sub-category of cost-effectiveness analysis whose use has to be duly justified) provided that there is strong evidence of equivalence in terms of clinical efficacy. If this is not the case, a cost-utility analysis will be more relevant as it will test simultaneously for both differences in efficacy and in costs.
Moreover, the study will confrim the safety of telecardiology and evaluate patients' individual preferences for the different management strategies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Other: Follow up post Pacemaker implantation by home monitoringin-office follow-up at 30 days post-implantation and after by remote monitoring (daily) without scheduled in-office follow-up during the study period (48 months). A remote FU will be planned every 9 months. |
| Control group | Active comparator | Other: Follow up post Pacemaker implantation in officeThe patients randomized in the control group will be followed accordingto the guidelines; i.e. with an in-office follow-up at 30 days post-implantation and after followed with in-office follow-ups according to clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Single or dual chamber pacemaker implantation patients
- patients agree to be enrolled in the study and followed during 4 years
- patients have insurance coverage
Key exclusion criteria (4 listed)
- Minor patients
- personn with disability
- pregnant women
- patient with life expectancy of less than 4 years
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 |
|---|---|---|
| Follow up post Pacemaker implantation in officeAll patients will be implanted with a single or dual chamber pacemaker according the implantation guidelines and will be followed by in-office follow-up | Other | Control group |
| Follow up post Pacemaker implantation by home monitoringAll patients will be implanted with a single or dual chamber pacemaker according the implantation guidelines and will be followed by home monitoring | Other | Active group |
Primary outcome
ICER (incremental cost effectivness ratio)
Time frame: 4 years
cost and medical consumtion collected with the French insurance care database
QALY
Time frame: 4 years
Quality Adjusted Life Years estimated by EQ5D-5L
2 secondary outcomes
Safety of home monitoring
Time frame: 4 years
Safety of home monitoring
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow up post Pacemaker implantation in office and Follow up post Pacemaker implantation by home monitoring in people with Single or Dual Chamber Pacemaker Implantation and Home Monitoring Follow-up, run by Nantes University Hospital at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
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?
ICER (incremental cost effectivness ratio) (time frame: 4 years). The study lists 2 primary outcomes in all. 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 6 Jun 2023.