N/A
N=354
Full Automaticity and Remote Follow-up
Tachyarrhythmia
Bottom Line
View on ClinicalTrials.gov: NCT01526629 ↗Enrolled (actual)
354
Serious AEs
21.2%
Results posted
Jun 2017
Primary outcome: Primary: Remote Follow-up as an Alternative to Onsite Visit — 203 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Remote Follow-up as an Alternative to Onsite Visit |
203 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01526629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.