N/A
Completed N=162
Detect Fluid Early From Intra-thoracic Impedance Monitoring
Source: ClinicalTrials.gov NCT00916929 ↗Enrolled (actual)
162
Serious AEs
3.1%
Results posted
Jun 2013
Primary outcomePrimary: False Positive Rate — 1.8; 1.49 departures from device threshold
Summary
To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY False Positive Rate |
1.8; 1.49 | — |
| SECONDARY Sensitivity |
40; 30.8 | — |
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. Informational only — not medical advice.