Demonstrate the sensitivity of the diagnostic feature "Physiological Diagnostic" (PhD) to detect clinically relevant HF-related events and to demonstrate a reasonable number of false positive indications.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity of the PhD-inication in detecting HF events (device indicated) in
relation to all HF-related clinical events.
At least one of the following present: hospital admission, emergency room visit
requiring intravenous drug treatment, invasive intervention, admission to
intensive care, initiation of intravenous drug treatment without hospital
admission, death.
Mean number of false positives per year per patient.
Success is defined as mean rate for study population statistically
significantly less than two false positives per patient per year.
Secondary outcome
Sensitivity of Paradym PhD-indication in detecting HF events (device indicated
HF event) in relation to all HF events related to oral treatment modification.
Reported co-morbidity that was related to a PhD-indication in the device memory.
Reported Adverse Events.
Background summary
Evaluation of an additional diagnostic function in a biventricular
defibrillator.
Study objective
Demonstrate the sensitivity of the diagnostic feature "Physiological
Diagnostic" (PhD) to detect clinically relevant HF-related events and to
demonstrate a reasonable number of false positive indications.
Study design
Prospective, multi-centre, non-randomized, pivotal trial.
Study burden and risks
No additional risk.
Paasheuvelweg 1
1100 AB Amsterdam
NL
Paasheuvelweg 1
1100 AB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Indication for biventricular defibrillator and chronic heart failure.
Exclusion criteria
Contraindication for standard pacing.
Contraindication for ICD therapy.
Abdominal implantation site.
Acute myocarditis.
Design
Recruitment
Medical products/devices used
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 | NL31468.075.10 |