Detect Fluid Early From Intra-thoracic Impedance Monitoring

Abbott Medical Devices34 sites in 1 country162 target enrollmentMay 2009

ConditionsHeart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Abbott Medical Devices
Enrollment: 162
Locations: 34
Primary Endpoint: False Positive Rate
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

March 2012

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

False Positive Rate

Time Frame: 6-months

False Positive Rate is the the number of departures from the device's programmed threshold that are unrelated to a heart failure event. The False Positive Rate per patient year of follow up should be less than 1.5.