Full Automaticity and Remote Follow-up

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

354 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Tachyarrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICD patients with remote follow-up

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No