Detect Fluid Early From Intra-thoracic Impedance Monitoring

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT00916929
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-10
• Primary Completion: 2011-02
• Study Completion: 2012-03
• Results First Submitted: 2012-12-18
• Results First Submitted QC: 2013-05-14
• Results First Posted: 2013-06-24
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
False Positive Rate	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 Outcome Measures

Name	Time	Method
Sensitivity	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).

Trial Locations

Locations (34)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Arizona Arrhythmia Research Center; 🇺🇸 Phoenix, Arizona, United States

Arkansas Cardiology, PA; 🇺🇸 Little Rock, Arkansas, United States

Little Rock Cardiology Clinic, PA; 🇺🇸 Little Rock, Arkansas, United States

Glendale Memorial Hospital and MC; 🇺🇸 Glendale, California, United States

Cardiac Rhythm Specialists, Inc; 🇺🇸 Northridge, California, United States

Colorado Cardiac Alliance, LLC; 🇺🇸 Colorado Springs, Colorado, United States

Shands Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Watson Clinic Center; 🇺🇸 Lakeland, Florida, United States

Orlando Heart Center; 🇺🇸 Orlando, Florida, United States

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