HVAD(TM) SMART 1.0 Study

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Device: Medtronic HeartWare ™ HVAD™ System

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult, advanced heart failure patients that meet patient selection criteria for left ventricular assist device (LVAD) implant for any approved indication and implant strategy will be considered for the study.

Description

Inclusion Criteria:

• Greater than or equal to 18 years of age:
• Refractory, advanced heart failure patient that is either: Prospectively identified as a candidate to receive the commercial HVAD system as their first durable left Ventricular Assist Device (LVAD) implant for approved indications; or within 10 days of receiving the commercial HVAD system as their first durable LVAD for approved indications
• Patient provides written authorization and/or consent per institution and geographical requirements

Exclusion Criteria:

• patient who is, or is expected to be inaccessible for follow up
• patient with previous durable mechanical circulatory support device
• patient with planned Bi-VAD procedure
• patient with exclusion criteria required by local law
• patient is currently enrolled in or plans to enroll in an concurrent drug and/or device study that may confound results (i.e., no required intervention that could affect interpretation of all-around product safety and/or effectiveness). Concomitant observational studies allowed if permitted by IRB/EC

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Failure Event Characterization	HVAD flow waveform and logfile pattern changes	data collected as events occur throughout study follow-up period; up to the 12 month follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualifying Adverse Event Characterization	Measuring HVAD flow waveform and logfile pattern changes for ICVA, HCVA, Pump Thrombosis (PT), GI Bleed, Sepsis, Supraventricular Arrhythmia, Ventricular Arrhythmia, or RHF.	data collected as events occur throughout study follow-up period; up to the 12 month follow-up visit
Non-AE/SAE Characterization Group	Measuring waveform and logfile for subjects in the previous 30 days free from: qualifying AE, hospital readmissions due to SAE, parenteral med therapy for HF management or ultrafiltration.	data collected throughout study follow-up period; up to the 12 month follow-up visit
CareLink Utilization	Characterizing the utility of CareLink and collect patient outcomes for: rate of unscheduled visits, rate or rehospitalization and length of stay, rate of qualifying AE and HF-related AE's, subject quality of life, and Patient & Physician satisfaction survey	Up to 12 months post-implant

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Christopher S Hayward, M.D., Lead PI; Principal Investigator: Mark S Slaughter, M.D., Lead PI

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): August 22, 2025
• Study Completion (Anticipated): August 22, 2025

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: July 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: MDT19054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes