Clinical trial NCT04854200: HVAD(TM) SMART 1.0 Study
Official title: HVAD(TM) SMART 1.0 Study: A Prospective Study of the HVAD(TM) SysteM WAvefoRm and Logfile CharacTeristics
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2021-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Heart Failure Event Characterization
timeFrame: data collected as events occur throughout study follow-up period; up to the 12 month follow-up visit
Secondary outcomes:
measure: Qualifying Adverse Event Characterization
timeFrame: data collected as events occur throughout study follow-up period; up to the 12 month follow-up visit
measure: Non-AE/SAE Characterization Group
timeFrame: data collected throughout study follow-up period; up to the 12 month follow-up visit
measure: CareLink Utilization
timeFrame: Up to 12 months post-implant
Other outcomes:
Locations:
Study officials:
affiliation: Lead PI
name: Christopher S Hayward, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lead PI
name: Mark S Slaughter, M.D.
role: PRINCIPAL_INVESTIGATOR
References: