N/A
N=162
Detect Fluid Early From Intra-thoracic Impedance Monitoring
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00916929 ↗Enrolled (actual)
162
Serious AEs
3.1%
Results posted
Jun 2013
Primary outcome: Primary: False Positive Rate — 1.8; 1.49 departures from device threshold
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Impedance Monitoring Feature (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY False Positive Rate |
1.8; 1.49 | — |
| SECONDARY Sensitivity |
40; 30.8 | — |
Summary
To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.
Eligibility Criteria
Inclusion Criteria
- Must have a St. Jude Medical (SJM) ICD or CRT-D for at least 31 days
- Must have had an episode of acute decompensated heart failure (ADHF) within the past 6 months
Exclusion Criteria
- History of kidney disease requiring hemodialysis
- Refractory end stage heart failure
Data sourced from ClinicalTrials.gov (NCT00916929). 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.