Full Automaticity and Remote Follow-up

Tachyarrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01526629
• Other study ID #: 1047
• Status: Active, not recruiting
• Phase: N/A
• First received: November 14, 2011
• Last updated: December 18, 2013
• Start date: May 2011
• Est. completion date: March 2015

Study information

• Verified date: December 2013
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesFrance: The Commission nationale de l’informatique et des libertésFrance: Conseil National de l'Ordre des Médecins
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 385
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tachyarrhythmia

Locations

Country	Name	City	State
France	CH Montfermeil	Montfermeil

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Profile of patient with remote follow-up requiring a site visit	Identification of the profile of patients implanted with a fully automatic ICD and remotely followed-up that requires a site visit	1 year	No
Secondary	Remote follow-up as an alternative to onsite visit	Evaluate in which proportion remote follow-up may represent an alternative to onsite visit for patients implanted with a fully automatic ICD	1 year	No
Secondary	Capacity to predict the need for onsite FU based on the analysis of remote follow-up data	Evaluate the sensibility and specificity of remote follow-up data to predict the need of an onsite visit; Sensibility is defined as follows: Number of cases where remote FU data analysis has shown reliably the need of an onsite visit divided by the total number of cases where an onsite was needed as defined per protocol.; Specificity is defined as follows: Number of cases where remote FU data analysis has shown reliably that there was no need for an onsite visit divided by the total number of cases where there was no need for an onsite visit.	1 year	No
Secondary	Type of reprogramming during onsite visits	Describe the type of reprogramming performed during onsite visits	1 year	No
Secondary	Patient constraints associated with an onsite visit	Describe patient constraints associated with an onsite visit	1 year	No