HVAD(TM) SMART 1.0 Study

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Device: Medtronic HeartWare ™ HVAD™ System


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

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 |