Full Automaticity and Remote Follow-up

Medtronic

Status: Completed

Conditions: Tachyarrhythmia

Study type: Observational

Funder types: Industry

Identifiers

NCT01526629

1047

Details and patient eligibility

About

With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the recent years. This has resulted in an increase of the number of follow-up (FU) to be performed and a growing workload for centers. Remote FU system such as the Medtronic Carelink system allows to check remotely the proper functioning of self evaluating devices and give informations of some clinical events.

The objective of this study is to define which patients with a remote follow-up need additional onsite visit and to assess to which extent remote FU can be an alternative to onsite visit.

Enrollment: 354 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient older than 18,
• Patient implanted with a fully automatic ICD and remotely followed-up,
• Patient geographically stable and able to attend FU at investigative site
• Patient who signed a data release authorization form,

Exclusion criteria

• Patient whose mental or physical capacity impedes to give an informed data release authorization,
• Patient already enrolled in a clinical study whose procedures may interfere with the results of the present study,
• Patients in New York Heart Association (NYHA) class IV

Trial design

354 participants in 1 patient group

ICD patients with remote follow-up

Description:

Patients implanted with a fully automatic ICD and remotely followed-up.