Decompensation Detection Study

Boston Scientific

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT00583089

DECODE

Details and patient eligibility

About

To gather data and analyze decompensation events.

Enrollment: 699 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients implanted with an approved Guidant CRT-D HF device programmed to CRT therapy in VDD or DDD mode.
• Patients prescribed to the LATITUDE(R) system configured for at least weekly device interrogations and symptoms reporting.
• Patients willing to use the LATITUDE(R) enabled weight scale.

Exclusion criteria

• Patients that require adaptive rate pacing (rate-responsive modes).
• Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days.
• Both

Trial design

699 participants in 2 patient groups

1

Description:

Algorithm Test Set

2

Description:

Algorithm Development Set