Detect Fluid Early From Intra-thoracic Impedance Monitoring

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Impedance Monitoring Feature

Device

Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads

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.

Secondary outcomes

Sensitivity

Time frame: 6-months

Sensitivity is defined as the ability of the algorithm to detect heart failure events. Sensitivity is calculated as the number of heart failure events detected by the algorithm (true positives) divided by the total number of heart failure events (true positives + false positives).

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: DEFEAT-PE

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2012
First posted: Jun 10, 2009
Registry last updated: Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed