Tachyarrhythmia Clinical Trial
Official title:
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | CH Montfermeil | Montfermeil |
Lead Sponsor | Collaborator |
---|---|
Medtronic Bakken Research Center | Medtronic |
France,
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 |
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