NCT04854200

HVAD(TM) SMART 1.0 Study

HVAD(TM) SMART 1.0 Study: A Prospective Study of the HVAD(TM) SysteM WAvefoRm and Logfile CharacTeristics

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of HVAD Smart 1.0 study is to collect HVAD device data (i.e., waveform + logfile + pump parameter) in various clinical conditions (e.g., routine follow-up visits, experiencing adverse events) to support development of predictive and actionable algorithms. The collected data will be used to characterize HVAD flow waveform and logfile pattern changes that precede a qualifying adverse event, as well as characterize "normal" HVAD flow waveform and logfile patterns (subjects free from any qualifying adverse event, any hospital readmissions related to a SAE, or any parenteral medical therapy for heart failure management (e.g., inotropes, diuretics, etc.) or ultrafiltration in last 30 days). In addition, the study will collect data to evaluate the utility of CareLink in HVAD patients. The study will not involve any investigational testing and the market-released devices will used as per the approved labelling.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DEVICE	Medtronic HeartWare ™ HVAD™ System	The Medtronic HeartWare™ HVAD™ System includes a ventricular assist device (VAD) that helps the heart pump and increases the amount of blood that flows through the body in patients with advanced heart failure.

Timeline

• Start date: 2021-05-01
• Primary completion: 2025-08-22
• Completion: 2025-08-22
• First posted: 2021-04-22
• Last updated: 2021-08-05

Regulatory

• FDA-regulated device study