Tachyarrhythmia
Conditions
Keywords
ICD, Remote follow-up
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.
Interventions
None listed
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ICD Patients With Remote Follow-up Patients implanted with a fully automatic ICD and remotely followed-up. | 354 |
| Total | 354 |
Baseline characteristics
| Characteristic | ICD Patients With Remote Follow-up |
|---|---|
| Age, Customized Men | 65 years |
| Age, Customized Women | 56 years |
| Region of Enrollment France | 354 participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 288 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 354 |
| serious Total, serious adverse events | 75 / 354 |
Outcome results
Primary
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
Time frame: 13 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ICD Patients With Remote Follow-up | Remote Follow-up as an Alternative to Onsite Visit | 203 Participants |