Telecardiology Clinical Trial
— SAFECAREOfficial title:
Safety Acceptability and Benefits of Tracking Cardiac Pacemakers by Carelink Express
| Verified date | January 2024 |
| Source | University Hospital, Brest |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Follow-up strategy for patients implanted with a pacemaker.
| Status | Terminated |
| Enrollment | 50 |
| Est. completion date | November 13, 2023 |
| Est. primary completion date | November 13, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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) - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU Brest | Brest | |
| France | CH Lorient | Lorient |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Brest |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | 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. | 2 years | |
| Secondary | Quality of life | Quality of life questionnaires will be submitted to patients | 2 years | |
| Secondary | 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 |