N/A
N=3,362
Actions Elicited by In-hospital Follow-up of Cardiac Devices
Cardiac Pacemaker, Artificial · Implantable Cardioverter-Defibrillator
Bottom Line
View on ClinicalTrials.gov: NCT01073449 ↗Enrolled (actual)
3,362
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up — 767 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- In-hospital follow-up of cardiac device (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Cliniche Humanitas Gavazzeni
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up |
767 | — |
| SECONDARY Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up |
512 | — |
| SECONDARY Number of Patients - Amongst Those Implanted With an Implantable Cardioverter Defibrillator (ICD)- in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up |
129 | — |
Summary
This study will enroll all patients who will attend an in-hospital follow-up of cardiac device since February 22nd 2010 to June 21st 2010.
Primary objective of the study is to observe how many of patients seen during these period (approximately 5000) will receive a change in cardiac device programming or in drug therapy or a scheduled or urgent hospital admission.
These data should help to clarify how useful and safe is a remote monitoring strategy for this kind of patients.
Eligibility Criteria
Inclusion Criteria
- All patients with a cardiac device
Exclusion Criteria
- Follow-up of a cardiac device at discharge from hospital after first implant
Data sourced from ClinicalTrials.gov (NCT01073449). 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.