Detect Fluid Early From Intra-thoracic Impedance Monitoring (DEFEAT-PE)

Abbott

Status: Completed

Conditions: Heart Failure

Treatments: Device: Impedance Monitoring Feature

Study type: Interventional

Funder types: Industry

Identifiers

NCT00916929

40006062/D

Details and patient eligibility

About

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

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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162 participants in 2 patient groups

Implantable Cardioverter Defibrillator (ICD)

Other group

Description:

Impedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD).

Treatment:

Device: Impedance Monitoring Feature

Cardiac Resynchronization Therapy (CRT-D)

Other group

Description:

Impedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device.

Treatment:

Device: Impedance Monitoring Feature