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decision by the promoter and funder following recruitment difficulties
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Follow-up strategy for patients implanted with a pacemaker.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Group | Experimental | A single visit 1 to 3 months after implantation then followed by the attending cardiologist. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow-up by Carelink express | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 years |
| In-depth sociological study carried out through questionnaires and individual interviews |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Mansourati, Professor | University Hospital, Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Brest | Brest | 29200 | France | |||
| CH Lorient |
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| Follow-up according to the usual recommendations | Other | 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). |
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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. |
| 2 years |
| Quality of life | Quality of life questionnaires will be submitted to patients | 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. | 2 years |
| Lorient |
| 56322 |
| France |