NCT02698241

Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only), investigational, feasibility study. The purpose of this study is to characterize safety of managing heart failure patients with integrated device diagnostics that have an implanted commercially available Medtronic cardiac resynchronization therapy defibrillator (CRT-D).

Detailed 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Diagnostic & Medication Management	Single Arm Study. Subjects will be managed using integrated diagnostics.

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2016-03-03
• Last updated: 2019-12-30
• Results posted: 2019-12-09

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study