Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-29 @ 12:24 PM
Study NCT ID:
NCT03140150
Status:
TERMINATED
Last Update Posted:
2024-01-10
First Post:
2017-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Acceptability and Benefits of Tracking Cardiac Pacemakers by Carelink Express
Sponsor:
University Hospital, Brest
Organization:
Study Overview
Official Title:
Safety Acceptability and Benefits of Tracking Cardiac Pacemakers by Carelink Express
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
decision by the promoter and funder following recruitment difficulties
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFECARE
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: