HVAD(TM) SMART 1.0 Study

Withdrawn

• Conditions: Chronic Heart Failure

• Registration Number: NCT04854200
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-22
• Study Start: 2021-05-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-05
• Primary Completion: 2025-08-22
• Study Completion: 2025-08-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
CareLink Utilization	Up to 12 months post-implant	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
Qualifying Adverse Event Characterization	data collected as events occur throughout study follow-up period; up to the 12 month follow-up visit	Measuring HVAD flow waveform and logfile pattern changes for ICVA, HCVA, Pump Thrombosis (PT), GI Bleed, Sepsis, Supraventricular Arrhythmia, Ventricular Arrhythmia, or RHF.
Non-AE/SAE Characterization Group	data collected throughout study follow-up period; up to the 12 month follow-up visit	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.