Full Automaticity and Remote Follow-up

Completed

• Conditions: Tachyarrhythmia

• Registration Number: NCT01526629
• Lead Sponsor: Medtronic Bakken Research Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2012-02-03
• Study First Posted: 2012-02-06
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2017-02
• Results First Submitted: 2017-02-14
• Results First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Results First Posted: 2017-06-29
• Last Update Posted: 2017-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 354

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remote Follow-up as an Alternative to Onsite Visit	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

Trial Locations

Locations (1)

CH Montfermeil; 🇫🇷 Montfermeil, France