Chronic Heart FailureNCT04854200
HVAD(TM) SMART 1.0 Study
An observational study of Chronic Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Medtronic HeartWare ™ HVAD™ System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 22 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Chronic Heart Failure
- Being tested
- Medtronic HeartWare ™ HVAD™ System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic HeartWare ™ HVAD™ SystemDevice
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 being measured
The primary outcome is the main question the study is designed to answer.
Heart Failure Event Characterization
HVAD flow waveform and logfile pattern changes
Measured: 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
Measuring HVAD flow waveform and logfile pattern changes for ICVA, HCVA, Pump Thrombosis (PT), GI Bleed, Sepsis, Supraventricular Arrhythmia, Ventricular Arrhythmia, or RHF.
Measured: 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.
Measured: 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
Measured: Up to 12 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion22 Aug 2025 (estimated)
- Study completion22 Aug 2025 (estimated)
Why it stopped: Product pulled off the market/Production of product stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher S Hayward, M.D., Principal investigator, Lead PIMark S Slaughter, M.D., Principal investigator, Lead PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854200
- Sponsor's protocol ID
- MDT19054
- Status last verified
- Jul 2021
- First submitted
- 25 Mar 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HVAD(TM) SMART 1.0 Study: A Prospective Study of the HVAD(TM) SysteM WAvefoRm and Logfile CharacTeristics
- ClinicalTrials.gov ID
- NCT04854200
- Acronym / sponsor ID
- MDT19054
- Conditions
- Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Product pulled off the market/Production of product stopped
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 22 Aug 2025 (estimated)
- Study completion
- 22 Aug 2025 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic HeartWare ™ HVAD™ SystemThe 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. | Device | – |
Primary outcome
Heart Failure Event Characterization
Time frame: 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
3 secondary outcomes
Qualifying Adverse Event Characterization
Time frame: data collected as events occur throughout study follow-up period; up to the 12 month follow-up visit
Non-AE/SAE Characterization Group
Time frame: data collected throughout study follow-up period; up to the 12 month follow-up visit
CareLink Utilization
Time frame: Up to 12 months post-implant
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher S Hayward, M.D. principal investigator
Lead PI
Mark S Slaughter, M.D. principal investigator
Lead PI
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Failure Event Characterization (time frame: data collected as events occur throughout study follow-up period; up to the 12 month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.