Full Automaticity and Remote Follow-up

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

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.

Study Overview

• Status: Completed
• Conditions: Tachyarrhythmia

• Study Type: Observational
• Enrollment (Actual): 354

Contacts and Locations

Study Locations

• France
  • Montfermeil, France, 93370
    • Ch Montfermeil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient implanted with a sigle- or dual-chamber ICD or a Cardiac Resynchronization-Defibrillator system (CRT-D) and remotely followed-up

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ICD patients with remote follow-up; Patients implanted with a fully automatic ICD and remotely followed-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remote Follow-up as an Alternative to Onsite Visit	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	13 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Collaborators: Medtronic
• Investigators: Principal Investigator: Walid Amara, MD, Centre Hospitalier de Montfermeil

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: November 14, 2011
• First Submitted That Met QC Criteria: February 3, 2012
• First Posted (Estimated): February 6, 2012

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: ICD; Remote follow-up
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia
• Other Study ID Numbers: 1047