NCT03140150

Safety Acceptability and Benefits of Tracking Cardiac Pacemakers by Carelink Express

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Telecardiology

Interventions

Type	Name	Description
DEVICE	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
OTHER	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).

Timeline

• Start date: 2017-12-26
• Primary completion: 2023-11-13
• Completion: 2023-11-13
• First posted: 2017-05-04
• Last updated: 2024-01-10

Locations

2 sites across 1 country: France