To investigate the clinical value of OptiVol (TM) impedance measurement by Medtronic(R) InSync Sentry(TM) ICD's. We aim to determine specificity and sensitivity for detecting heart failure. With collected data we want to design a protocol for…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
number of true positive OptiVol (TM) alarms
Secondary outcome
not applicable
Background summary
Decompensated heart failure is an important reason for hospitalisation in
patients with chronic heart failure. It is associated with an increased
morbidity and mortality. Scientific research has proven that intrathoracic
impedance measurement is able to detect decompensation in a preclinical phase.
This was reason for Medtronic (R) to implement a feature to measure impedance
in InSync Sentry (TM) ICD's. In literature little is known about the clinical
value of this feature.
Study objective
To investigate the clinical value of OptiVol (TM) impedance measurement by
Medtronic(R) InSync Sentry(TM) ICD's. We aim to determine specificity and
sensitivity for detecting heart failure. With collected data we want to design
a protocol for clinical practice.
Study design
Patients who have a Medtronic(R) InSync Sentry(TM) ICD will be included in our
study after informed consent. The OptiVol (TM) feature enabling impedance
measurement will be activated and at baseline data is collected (blood sample,
electrocardiography, transthoracal echocaradiography, chest X-ray and ICD
check-up). During follow-up patients will be reassesed in case of a OptiVol
alarm or in case of heart failure.
Study burden and risks
not applicable
Postbus 1350
5602 ZA Eindhoven
Nederland
Postbus 1350
5602 ZA Eindhoven
Nederland
Listed location countries
Age
Inclusion criteria
chronic heartfailure of any cause
implantation of Medtronic(R) InSync Sentry(TM) ICD
Exclusion criteria
impossibility to give informed-consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14316.060.06 |