HVAD(TM) SMART 1.0 Study

NCT04854200 | Withdrawn FDA Device

• 1 other identifier: MDT19054
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Qualifying Adverse Event Characterization

  data collected as events occur throughout study follow-up period; up to the 12 month follow-up visit

• Non-AE/SAE Characterization Group

  data collected throughout study follow-up period; up to the 12 month follow-up visit

• CareLink Utilization

  Up to 12 months post-implant

Interventions

Medtronic HeartWare ™ HVAD™ System DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Officials

• Christopher S Hayward, M.D.

  Lead PI

  PRINCIPAL INVESTIGATOR

• Mark S Slaughter, M.D.

  Lead PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 22, 2021
• Study Start: May 1, 2021
• Primary Completion: August 22, 2025
• Study Completion: August 22, 2025
• Last Updated: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share