Safety Acceptability and Benefits of Tracking Cardiac Pacemakers by Carelink Express (SAFECARE)

Regional University Hospital Center (CHRU)

Status: Terminated

Conditions: Telecardiology

Treatments: Device: Follow-up by Carelink express; Other: Follow-up according to the usual recommendations

Study type: Interventional

Funder types: Other

Identifiers

NCT03140150

SAFECARE

Details and patient eligibility

About

Follow-up strategy for patients implanted with a pacemaker.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Active Group

Experimental group

Description:

A single visit 1 to 3 months after implantation then followed by the attending cardiologist.

Treatment:

Device: Follow-up by Carelink express

Control Group

Other group

Description:

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).

Treatment:

Other: Follow-up according to the usual recommendations