Safety Acceptability and Benefits of Tracking Cardiac Pacemakers by Carelink Express
NCT ID: NCT03140150
Last Updated: 2024-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
50 participants
INTERVENTIONAL
2017-12-26
2023-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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Active Group
A single visit 1 to 3 months after implantation then followed by the attending cardiologist.
Follow-up by Carelink express
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
Control Group
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).
Follow-up according to the usual recommendations
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).
Interventions
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Follow-up by Carelink express
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 recommendations
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).
Eligibility Criteria
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Inclusion Criteria
* and accepting inclusion in the study.
* The patient should be followed by a city cardiologist participating in the study.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Jacques Mansourati, Professor
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Brest
Locations
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CHRU Brest
Brest, , France
CH Lorient
Lorient, , France
Countries
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Other Identifiers
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SAFECARE
Identifier Type: -
Identifier Source: org_study_id
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