Full Automaticity and Remote Follow-up

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.

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Key information

Conditions

Tachyarrhythmia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Montfermeil

Montfermeil, 93370, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Remote Follow-up as an Alternative to Onsite Visit

Time frame: 13 months

Evaluate the percentage of patients who had a successful remote follow up, as an alternative to onsite visit for patients implanted with a fully automatic ICD

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

Medtronic

Registry information

Official study title

Identification of Implantable Cardioverter Defibrillator Patients With Remote Follow up That Requires an Onsite Visit

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Feb 6, 2012
Registry last updated: Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed