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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Identification of Implantable Cardioverter Defibrillator Patients With Remote Follow up That Requires an Onsite Visit|
- Profile of patient with remote follow-up requiring a site visit [ Time Frame: 1 year ] [ Designated as safety issue: No ]Identification of the profile of patients implanted with a fully automatic ICD and remotely followed-up that requires a site visit
- Remote follow-up as an alternative to onsite visit [ Time Frame: 1 year ] [ Designated as safety issue: No ]Evaluate in which proportion remote follow-up may represent an alternative to onsite visit for patients implanted with a fully automatic ICD
- Capacity to predict the need for onsite FU based on the analysis of remote follow-up data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
- Type of reprogramming during onsite visits [ Time Frame: 1 year ] [ Designated as safety issue: No ]Describe the type of reprogramming performed during onsite visits
- Patient constraints associated with an onsite visit [ Time Frame: 1 year ] [ Designated as safety issue: No ]Describe patient constraints associated with an onsite visit
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
ICD patients with remote follow-up
Patients implanted with a fully automatic ICD and remotely followed-up.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526629
|Montfermeil, France, 93370|
|Principal Investigator:||Walid Amara, MD||Centre Hospitalier de Montfermeil|