Pacemaker DddSTARTNCT03876600
Cost-utility Analysis of Ambulatory Care Compared to Conventional Patient Care of Permanent Pacemakers Replacement for Elective Replacement Indicator
A study testing Replacement of permanent pacemakers for elective wear. in people with Pacemaker Ddd, run by Nantes University Hospital at 14 sites in France.
Trial summary
START study is a comparison of cost-utility between permanent pacemaker replacement ambulatory care and permanent pacemaker replacement conventional hospitalization care. The hypothesis of the study is that ambulatory care compared to conventional hospitalization, involving a stay of more than 24 hours, would reduce… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker Ddd
- What is being tested?
- Replacement of permanent pacemakers for elective wear.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 14 sitesFrance
- Study dates
- Apr 2019to Apr 2022
- 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
- Man or woman over 18 years old.
- Replacement of permanent pacemakers for battery elective wear without programmed act in the sensors regardless of pacemaker type, simple, dual or triple chambers and regardless pacemaker label.
- Patient living less than an hour from a hospital center
- Patient is able to answer the phone.
- Patient has an accompaniment the go out night
- Pacemaker-dependent patient or not regardless of indication of placement of the pacemaker
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- Patient with or without anticoagulant treatment: the anticoagulant treatment is managed by center under these habits.
- Patient has given this free and informed consent.
- Patient having insurance in France.
Who cannot join
- Ambulatory Hospitalization is impossible.
- Patient refuses to participate
- Patient has hemostasis disorder yielding ambulatory hospitalization impossible.
- Woman is pregnant, nursing mothers or the patient don't receive an effective contraception.
- Patient under guardianship, safeguard of justice
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Angers University Hospital
Angers, 49933
Jean-Marc Dupuis, jeanmarc.dupuis@chu-angers.fr
Jean-Marc Dupuis, PH
Brest University Hospital
Brest, 29200
Jacques Mansourati, jacques.mansourati@chu-brest.fr
Jacques Mansourati, PUPH
Dijon University Hospital
Dijon, 21079
Laurent Gabriel, gabriel.laurent@chu-dijon.fr
Laurent Gabriel, PUPH
Grenoble University Hospital
Grenoble, 38000
Pascal Defaye, pdefaye@chu-grenoble.fr
Pascal Defaye, PUPH
Lyon University Hospital
Lyon, Bron, 69677
Philippe Chevalier, philippe.chevalier@chu-lyon.fr
Philippe Chevalier, PUPH
AP-HM
Marseille, 13005
Jean-Claude Deharo, eanclaude.deharo@ap-hm.fr
Jean-Claude Deharo, PUPH
Montpellier University Hospital
Montpellier, 34295
Jean-Luc Pasquié, jl-pasquie@chu-montpellier.fr
Jean-Luc Pasquié, PUPH
Nancy University Hospital
Nancy, 54511
Nicolas Sadoul, n.sadoul@chru-nancy.fr
Nicolas Sadoul, PUPH
AP-HP, La Pitié Salpétrière
Paris, 75013
Estelle Grandjbach, estelle.gbk@gmail.com
Estelle Grandjbach, PH
Rennes University Hospital
Rennes, 35033
Philippe Mabo, philippe.mabo@chu-rennes.fr
Philippe Mabo, PUPH
Saint-Etienne University Hospital
Saint-Etienne, 42100
Antoine Da Costa, antoine.dacosta@univ-st-etienne.fr
Antoine Da Costa, PUPH
Strasbourg University Hospital
Strasbourg
Laurence Jesel, laurence.jesel@chru-strasbourg.fr
Laurence Jesel, PH
Toulouse University Hospital
Toulouse, 31059
Pierre Mondoly, mondoly.p@chu-toulouse.fr
Pierre Mondoly, PH
Tours University Hopsital
Tours, 37044
Dominique Babuty, d.babuty@chu-tours.fr
Dominique Babuty, PUPH
About this study
START study is a comparison of cost-utility between permanent pacemaker replacement ambulatory care and permanent pacemaker replacement conventional hospitalization care.
The hypothesis of the study is that ambulatory care compared to conventional hospitalization, involving a stay of more than 24 hours, would reduce hospitalization and care expenses without loss of quality of care and without increasing the complication rate for patients.
Read the detailed description
In France, nearly 49,000 permanent pacemakers are implanted each year. The pacemaker longevity is about 10 years which leads to their replacement.
In France, in 2016, 15,764 pacemaker replacement hospital stays took place. 10.6% of them were made during an outpatient stay, 12.4% during a one-night hospitalization and 70.7% during hospitalization for two or more than two nights for the severity level 1.
If the outpatient care management is deployed at 90%, the economy of the cost care will be estimated to be 3,5 million euros and a reduction of 15 582 hospitalization night's stay.
The aim of START study is to compare cost-utility between ambulatory and conventional hospitalization care of permanent pacemakers replacement for elective replacement indicator and to demonstrate equivalence between outpatient management and conventional hospitalization management.
This study is in adequation with the national ambition to deploy the outpatient management in France. Surgery is the same with both hospitalization managements.
An ambulatory surgery need to present different advantages and benefits like high quality care and substantial cost savings.
The benefits of ambulatory care management are :
- An economy of hospitalization nights cost.
- A decrease in health costs related to the surgery realization.
- Patient satisfaction expected due to hospital discharged within 24 hours. Patient is expected to go home the same day as the surgery with good perception of ambulatory surgery.
- A decrease in the disorientation risk in the elderly patient is also expected.
Surgery is the same with both hospitalization managements.
Patients will be randomized in 2 arms. An arm conventional hospitalization management (control arm) and an arm outpatient care management.
Study period is 30 months. Patients will be following during 6 months. The recruitment time will be 24 months.
- Conditions
- Pacemaker Ddd
- Being tested
- Replacement of permanent pacemakers for elective wear.
- Keywords
- pacemaker, replace for elective wear, french context, cost-utility analysis, prospective, multicentric, randomized study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Replacement of permanent pacemakers for elective wear.Procedure or surgery
START's intervention is a replacement of permanent pacemakers for elective wear, for the both arms the surgical intervention is the same. The surgical procedure is the same in the both arms.
The differences are in conventional hospitalization, patient comes to hospital one day before operation and he can go out one day after operation. In ambulatory patient come to hospital operation days and he can got out the same day.
| Study group | Role | What they receive |
|---|---|---|
| conventional hospitalization management. | Experimental | The patients who are randomized to have a conventional hospitalization for the pacemaker replacement have conventional management.
In this management patient come to hospital one day before this surgical operation and he is operated next day Receives: Procedure: Replacement of permanent pacemakers for elective wear. |
| ambulatory management | Active comparator | The patients who are randomized to have a ambulatory surgery for the pacemaker replacement have ambulatory management.
In the ambulatory hospitalization patients come to hospital and have a surgical operation the same day Receives: Procedure: Replacement of permanent pacemakers for elective wear. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-utility analysis,from the perspective of the society and a time horizon of 6 months,of ambulatory management compared to the intervention in conventional hospitalization of a replacement,for elective wear,permanent pacemakers
Incremental cost-utility ratio (cost by quality-adjusted life-years, QALY) of outpatient management compared to compared to the intervention in conventional hospitalization (≥1 night) of a replacement, for elective wear, permanent pacemakers. This analysis is from the perspective of the society and a time horizon of 6 months.
Measured: 6 month
Secondary outcomes (4)
Assess, the point of view of health insurance and health care institutions with a time horizon of 5 years, the annual and global budgetary impact in € of different diffusion scenarios for ambulatory to replace conventional hospitalization
Annual and global net profit cost in € of different diffusion scenarios for ambulatory to replace conventional hospitalization.
Measured: on a time horizon of 5 years
Evaluate and compare the rate of complications of different management within 6 months after the intervention in both arms.
Complication statement requiring a rehospitalization with reoperation. This objective is assessed by the complication statement requiring rehospitalization without reoperation and complication with not requiring rehospitalization.
Measured: on time horizon of 6 months
Evaluate the ambulatory failure rate
Ambulatory failure rate. It is a ratio of the number of ambulatory visits converted to conventional hospitalization and the total number of ambulatory visits.
Measured: during all the study, during 30 months.
Evaluate and compare patients satisfaction between intervention and hospital management in both arms
Satisfaction with the intervention and management at the hospital with questionnaire
Measured: during hospitalization, during 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker DddStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Vincent Probst, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876600
- Sponsor's protocol ID
- RC18_0034
- Acronym
- START
- Status last verified
- Feb 2019
- First submitted
- 14 Feb 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-utility Analysis of Ambulatory Care Compared to Conventional Patient Care of Permanent Pacemakers Replacement for Elective Replacement Indicator
- ClinicalTrials.gov ID
- NCT03876600
- Acronym / sponsor ID
- START / RC18_0034
- Conditions
- Pacemaker Ddd
- Keywords
- pacemaker, replace for elective wear, french context, cost-utility analysis, prospective, multicentric, randomized study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Apr 2019 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 15 Mar 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.
START study is a comparison of cost-utility between permanent pacemaker replacement ambulatory care and permanent pacemaker replacement conventional hospitalization care.
The hypothesis of the study is that ambulatory care compared to conventional hospitalization, involving a stay of more than 24 hours, would reduce hospitalization and care expenses without loss of quality of care and without increasing the complication rate for patients.
Detailed description
In France, nearly 49,000 permanent pacemakers are implanted each year. The pacemaker longevity is about 10 years which leads to their replacement.
In France, in 2016, 15,764 pacemaker replacement hospital stays took place. 10.6% of them were made during an outpatient stay, 12.4% during a one-night hospitalization and 70.7% during hospitalization for two or more than two nights for the severity level 1.
If the outpatient care management is deployed at 90%, the economy of the cost care will be estimated to be 3,5 million euros and a reduction of 15 582 hospitalization night's stay.
The aim of START study is to compare cost-utility between ambulatory and conventional hospitalization care of permanent pacemakers replacement for elective replacement indicator and to demonstrate equivalence between outpatient management and conventional hospitalization management.
This study is in adequation with the national ambition to deploy the outpatient management in France. Surgery is the same with both hospitalization managements.
An ambulatory surgery need to present different advantages and benefits like high quality care and substantial cost savings.
The benefits of ambulatory care management are :
- An economy of hospitalization nights cost.
- A decrease in health costs related to the surgery realization.
- Patient satisfaction expected due to hospital discharged within 24 hours. Patient is expected to go home the same day as the surgery with good perception of ambulatory surgery.
- A decrease in the disorientation risk in the elderly patient is also expected.
Surgery is the same with both hospitalization managements.
Patients will be randomized in 2 arms. An arm conventional hospitalization management (control arm) and an arm outpatient care management.
Study period is 30 months. Patients will be following during 6 months. The recruitment time will be 24 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional hospitalization management. | Experimental | Procedure: Replacement of permanent pacemakers for elective wear.The patients who are randomized to have a conventional hospitalization for the pacemaker replacement have conventional management. In this management patient come to hospital one day before this surgical operation and he is operated next day |
| ambulatory management | Active comparator | Procedure: Replacement of permanent pacemakers for elective wear.The patients who are randomized to have a ambulatory surgery for the pacemaker replacement have ambulatory management. In the ambulatory hospitalization patients come to hospital and have a surgical operation the same day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Man or woman over 18 years old.
- Replacement of permanent pacemakers for battery elective wear without programmed act in the sensors regardless of pacemaker type, simple, dual or triple chambers and regardless pacemaker label.
- Patient living less than an hour from a hospital center
- Patient is able to answer the phone.
- Patient has an accompaniment the go out night
Key exclusion criteria (5 listed)
- Ambulatory Hospitalization is impossible.
- Patient refuses to participate
- Patient has hemostasis disorder yielding ambulatory hospitalization impossible.
- Woman is pregnant, nursing mothers or the patient don't receive an effective contraception.
- Patient under guardianship, safeguard of justice
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 |
|---|---|---|
| Replacement of permanent pacemakers for elective wear.START's intervention is a replacement of permanent pacemakers for elective wear, for the both arms the surgical intervention is the same. The surgical procedure is the same in the both arms. The differences are in conventional hospitalization, patient comes to hospital one day before operation and he can go out one day after operation. In ambulatory patient come to hospital operation days and he can got out the same day. | Procedure or surgery | ambulatory management, conventional hospitalization management. |
Primary outcome
Cost-utility analysis,from the perspective of the society and a time horizon of 6 months,of ambulatory management compared to the intervention in conventional hospitalization of a replacement,for elective wear,permanent pacemakers
Time frame: 6 month
Incremental cost-utility ratio (cost by quality-adjusted life-years, QALY) of outpatient management compared to compared to the intervention in conventional hospitalization (≥1 night) of a replacement, for elective wear, permanent pacemakers. This analysis is from the perspective of the society and a time horizon of 6 months.
4 secondary outcomes
Assess, the point of view of health insurance and health care institutions with a time horizon of 5 years, the annual and global budgetary impact in € of different diffusion scenarios for ambulatory to replace conventional hospitalization
Time frame: on a time horizon of 5 years
Evaluate and compare the rate of complications of different management within 6 months after the intervention in both arms.
Time frame: on time horizon of 6 months
Evaluate the ambulatory failure rate
Time frame: during all the study, during 30 months.
Evaluate and compare patients satisfaction between intervention and hospital management in both arms
Time frame: during hospitalization, during 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Vincent Probst principal investigator
Nantes University Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Replacement of permanent pacemakers for elective wear. in people with Pacemaker Ddd, run by Nantes University Hospital at 14 sites 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 9 inclusion and 5 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 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Contact Vincent Probst (0240165093, vincent.probst@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-utility analysis,from the perspective of the society and a time horizon of 6 months,of ambulatory management compared to the intervention in conventional hospitalization of a replacement,for elective wear,permanent pacemakers (time frame: 6 month). 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 15 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.