TelecardiologySAFECARENCT03140150
Safety Acceptability and Benefits of Tracking Cardiac Pacemakers by Carelink Express
A study testing Follow-up by Carelink express and Follow-up according to the usual recommendations in people with Telecardiology, run by University Hospital, Brest at 2 sites in France.
Trial summary
Follow-up strategy for patients implanted with a pacemaker. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telecardiology
- What is being tested?
- Follow-up by Carelink express and Follow-up according to the usual recommendations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Dec 2017to 13 Nov 2023
- 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
- Any patient implanted with a Medtronic brand AAI (R), VVI (R) and DDD (R) cardiac pacemaker, allowing transmission via Carelink Express (Medtronic)
- and accepting inclusion in the study.
- The patient should be followed by a city cardiologist participating in the study.
Who cannot join
- Age <18 years
- Pregnant or likely to become pregnant during the study
- Patient with an unstable medical condition, NYHA Class IV Heart Failure
- Presence of psychiatric illness, depression, anxiety disorder
- Presence of diseases, other than heart disease, responsible for a reduction in life expectancy for the duration of the study.
- Patient unable to follow protocol (respond to questionnaires)
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- Change of residence planned during the study
- Participation in an interventional and therapeutic clinical study; Patient participation in an observational study is permitted.
- Patient not signed consent form
- Patient under legal protection
Trial locations and contacts
2 sites in 1 country.
About this study
Follow-up strategy for patients implanted with a pacemaker.
Read the detailed description
This study seeks to verify that a follow-up strategy for patients implanted with a mono- or double-chamber pacemaker, stimuli-dependent or not, for 2 years, by means of data transmissions of the devices by Carelink Express during the usual consultations with the treating cardiologist significantly reduces the number of unnecessary consultations in the implant centers (without any change in treatment or pacemaker programming) compared to the usual follow-up mode recommended for this type of device.
- Conditions
- Telecardiology
- Being tested
- Follow-up by Carelink express, Follow-up according to the usual recommendations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up by Carelink expressDevice
Followed by the cardiologist exclusively using Carelink Express during the study period: a single visit 1 to 3 months after implantation, then followed by the cardiologist and interrogation of the stimulator by Carelink Express
Follow-up according to the usual recommendationsOther
According to follow-up recommendations for pacemakers, a visit is planned every 6 months if the patient is dependent on the stimulator (either visits to M6, M12, M18 and M24) or annually if the patient is not dependent on the stimulator (visits to M12 and M24).
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Experimental | A single visit 1 to 3 months after implantation then followed by the attending cardiologist. Receives: Device: Follow-up by Carelink express |
| Control Group | Other | A first visit 1 to 3 months after implantation and then every 6 months or every year according to the recommendations of pacemaker follow-up (ie 2 or 4 systematic visits during the follow-up of 2 years). Receives: Other: Follow-up according to the usual recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
At least one unnecessary consultation during two years of follow-up
The primary outcome measure will be at least one unnecessary consultation during two years of follow-up (apart from the first mandatory consultation in all patients)
Measured: 2 years
Secondary outcomes (4)
Occurrence of a serious adverse event
Comparison of the number of serious adverse events during follow-up in each arm (total mortality, hospitalizations for cardiac event, occurrence of a rhythmological event or related to the implanted device)
Measured: 2 years
In-depth sociological study carried out through questionnaires and individual interviews
A more in-depth study will be conducted through questionnaires and individual interviews, developed by sociologists, on representative samples of the two arms of the study (based on age, gender and type of domicile - Individual or collective housing - representative of the populations implanted in 2016) followed at a distance in terms of acceptability, impact on everyday life and the doctor-patient relationship. A survey will also be conducted with attending cardiologists to assess their acceptability of this type of follow-up.
Measured: 2 years
Quality of life
Quality of life questionnaires will be submitted to patients
Measured: 2 years
The medical economic evaluation to measure the efficiency of the device Carelink Express allowing patients' tele-monitoring implanted by a pacemaker
The main analysis will be a comparative cost study based on the following assumption: the direct costs of patient support are different from the direct costs of care for patients undergoing conventional monitoring, in particular in terms of the number Follow-up consultations and transport (COMPAS study: Mabo, 2011).
The complementary study will be a cost-utility analysis based on a utility measure obtained by the EQ-5D questionnaire.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start26 Dec 2017
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Why it stopped: decision by the promoter and funder following recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelecardiologyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Mansourati, Professor, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140150
- Sponsor's protocol ID
- SAFECARE
- Acronym
- SAFECARE
- Status last verified
- Jan 2024
- First submitted
- 13 Apr 2017
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Acceptability and Benefits of Tracking Cardiac Pacemakers by Carelink Express
- ClinicalTrials.gov ID
- NCT03140150
- Acronym / sponsor ID
- SAFECARE / SAFECARE
- Conditions
- Telecardiology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: decision by the promoter and funder following recruitment difficulties
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 26 Dec 2017 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 4 May 2017 (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.
Follow-up strategy for patients implanted with a pacemaker.
Detailed description
This study seeks to verify that a follow-up strategy for patients implanted with a mono- or double-chamber pacemaker, stimuli-dependent or not, for 2 years, by means of data transmissions of the devices by Carelink Express during the usual consultations with the treating cardiologist significantly reduces the number of unnecessary consultations in the implant centers (without any change in treatment or pacemaker programming) compared to the usual follow-up mode recommended for this type of device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Experimental | Device: Follow-up by Carelink expressA single visit 1 to 3 months after implantation then followed by the attending cardiologist. |
| Control Group | Other | Other: Follow-up according to the usual recommendationsA first visit 1 to 3 months after implantation and then every 6 months or every year according to the recommendations of pacemaker follow-up (ie 2 or 4 systematic visits during the follow-up of 2 years). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient implanted with a Medtronic brand AAI (R), VVI (R) and DDD (R) cardiac pacemaker, allowing transmission via Carelink Express (Medtronic)
- and accepting inclusion in the study.
- The patient should be followed by a city cardiologist participating in the study.
Key exclusion criteria (10 listed)
- Age <18 years
- Pregnant or likely to become pregnant during the study
- Patient with an unstable medical condition, NYHA Class IV Heart Failure
- Presence of psychiatric illness, depression, anxiety disorder
- Presence of diseases, other than heart disease, responsible for a reduction in life expectancy for the duration of the study.
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 by Carelink expressFollowed by the cardiologist exclusively using Carelink Express during the study period: a single visit 1 to 3 months after implantation, then followed by the cardiologist and interrogation of the stimulator by Carelink Express | Device | Active Group |
| Follow-up according to the usual recommendationsAccording to follow-up recommendations for pacemakers, a visit is planned every 6 months if the patient is dependent on the stimulator (either visits to M6, M12, M18 and M24) or annually if the patient is not dependent on the stimulator (visits to M12 and M24). | Other | Control Group |
Primary outcome
At least one unnecessary consultation during two years of follow-up
Time frame: 2 years
The primary outcome measure will be at least one unnecessary consultation during two years of follow-up (apart from the first mandatory consultation in all patients)
4 secondary outcomes
Occurrence of a serious adverse event
Time frame: 2 years
In-depth sociological study carried out through questionnaires and individual interviews
Time frame: 2 years
Quality of life
Time frame: 2 years
The medical economic evaluation to measure the efficiency of the device Carelink Express allowing patients' tele-monitoring implanted by a pacemaker
Time frame: 2 years
Results and safety
The study was stopped early (reason given: decision by the promoter and funder following recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
Related trials for Telecardiology
Active, not recruitingPhase 4
Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Patients With Acute Coronary Syndrome Associated With de Novo Atrial Fibrillation Arrhythmia
Atrial Fibrillation, Myocardial Infarction
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.
Jacques Mansourati, Professor principal investigator
University Hospital, Brest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up by Carelink express and Follow-up according to the usual recommendations in people with Telecardiology, run by University Hospital, Brest at 2 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 3 inclusion and 10 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 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was stopped early (reason given: decision by the promoter and funder following recruitment difficulties). 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?
At least one unnecessary consultation during two years of follow-up (time frame: 2 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 10 Jan 2024.