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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04854200
Study type Observational
Source Medtronic Cardiac Rhythm and Heart Failure
Contact HVAD SMART 1.0 Manager
Phone 707-566-1033
Email [email protected]
Status Not yet recruiting
Phase
Start date May 1, 2021
Completion date August 22, 2025

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