INTERVENE-HF

Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure

INTERVENE-HF [NCT02698241]

Description: The study is expected to be conducted at up to 20 centers located in the United States. Up to 400 subjects will be enrolled to yield up to 200 eligible subjects that meet screening criteria. This study will be conducted in subjects with an implanted, commercially available, Medtronic, CRT-D device. Each enrolled subject will be followed every 2 months from time of enrollment to end of the study.The study will end after the last enrolled subject completes the 12-month follow-up.
 
Device: Diagnostic & Medication Management

Primary Investigator: Menon

Drug/Device Information
The purpose of this clinical feasibility study is to gain experience with a research system that combines a device diagnostic based risk stratification algorithm with a guided work flow process
Managed by a centralized communication center
The basic INTERVENE-HF research system is comprised of the pre-existing Medtronic, CRT-D device, investigational 2090 programmer software and the INTERVENE Study Communication Center (ISCC)
The software is capable of turning ON/OFF the silent OptiVol wireless CareAlert
Prospective, non-randomized
Medtronic, Inc.