Advanced Heart FailureNCT04703855
Hong Kong and Taiwan HM3 PMS
A study testing HeartMate 3™ left ventricular assist system (HM3 LVAS) in people with Advanced Heart Failure, run by Abbott Medical Devices at 3 sites in 2 countries.
Trial summary
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Heart Failure
- What is being tested?
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 14 Jul 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- All patients at the participating sites that are determined to meet the HM3 commercially approved labelling indication and have a planned HM3 implant are eligible to participate in this PMS. Assessment for eligibility criteria is based on medical records of the site and interview with a candidate patient.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Taiwan2 sites
National Taiwan University Hospital
Taipei, 100
Tri-Service General Hospital
Taipei, 114
About this study
Official title: Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Hong Kong and Taiwan
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. The PMS will enroll approximately 30 patients, that meet the HM3 commercially approved labelling indications, from approximately 4 sites in Hong Kong and Taiwan. PMS participants will be followed until the 24 months follow-up visit or until they experience an outcome, whichever comes first.
- Conditions
- Advanced Heart Failure
- Being tested
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Keywords
- HeartMate 3, Left ventricular assist device, ABT-CIP-10382
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartMate 3™ left ventricular assist system (HM3 LVAS)Device
Advanced heart failure patients will be implanted with the HM3 LVAS
| Study group | Role | What they receive |
|---|---|---|
| HeartMate 3™ left ventricular assist system (HM3 LVAS) | Experimental | Patients will be implanted with the HM3 LVAS Receives: Device: HeartMate 3™ left ventricular assist system (HM3 LVAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: Number of Participants With Overall Survival to Transplant, Myocardial Recovery or on Device Support Free of Debilitating Stroke (Modified Rankin Score >3) or Reoperation for Pump Replacement
Overall survival to transplant, myocardial recovery or on device support free of debilitating stroke (Modified Rankin Score >3) or reoperation for pump replacement will be assessed using the Kaplan-Meier product-limit method along with a competing outcomes graph. Subjects who are urgently transplanted due to a HeartMate 3 malfunction will be considered to have experienced a primary endpoint event, as will subjects who expire, suffer a debilitating stroke or have their HeartMate 3 exchanged due to a device failure. Subjects who are transplanted (except as described above), explanted for recovery, withdraw from the trial or are lost to follow-up will be censored at that time in the analysis.
Measured: Up to 6 months follow-up
Primary Safety Endpoint: Number of Cumulative Occurrence of Adverse Events
Cumulative occurrence of adverse events will be presented as percent of patients with adverse events
Measured: Up to 6 months follow-up
Secondary outcomes (5)
Mean Change in Six-minute Walk Test From Baseline
The 6-minute Walk test will be conducted at all follow-up visits until the end of the surveillance period.
Measured: Baseline and 1 Month post-implant
Change Proportion of New York Heart Association (NYHA) Functional Status From Baseline
Subjects' NYHA Functional Status will be assessed at all scheduled follow-up visits until the end of the surveillance period.
The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Measured: Baseline and 1 Month post-implant
Mean Change in EQ-5D-5L VAS Quality of Life (QoL) From Baseline
The subject's quality of life will be measured by the EQ-5D-5L QoL questionnaire at baseline and all visits after the HM3 implant until the end of the surveillance period.
EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Measured: Baseline and 1 Month
Frequency of Rehospitalization and Reoperation
Frequency and reason will be reported for rehospitalization and reoperation.
Measured: Up to 6 months follow-up
Number of Participants With Device Malfunctions
All suspected HM3 device malfunctions will be reported.
Measured: Up to 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start14 Jul 2021
- Primary completion31 Mar 2022
- Study completion30 Jun 2022
Why it stopped: Low enrollment and regulatory status change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlo Gazzola, B. Sc., Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703855
- Sponsor's protocol ID
- ABT-CIP-10382
- Other IDs
- CRD 1022
- Status last verified
- Jun 2024
- First submitted
- 8 Jan 2021
- Last updated
- 1 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Hong Kong and Taiwan
- ClinicalTrials.gov ID
- NCT04703855
- Acronym / sponsor ID
- ABT-CIP-10382
- Conditions
- Advanced Heart Failure
- Keywords
- HeartMate 3, Left ventricular assist device, ABT-CIP-10382
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment and regulatory status change
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Posted 1 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. The PMS will enroll approximately 30 patients, that meet the HM3 commercially approved labelling indications, from approximately 4 sites in Hong Kong and Taiwan. PMS participants will be followed until the 24 months follow-up visit or until they experience an outcome, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HeartMate 3™ left ventricular assist system (HM3 LVAS) | Experimental | Device: HeartMate 3™ left ventricular assist system (HM3 LVAS)Patients will be implanted with the HM3 LVAS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients at the participating sites that are determined to meet the HM3 commercially approved labelling indication and have a planned HM3 implant are eligible to participate in this PMS. Assessment for eligibility criteria is based on medical records of the site and interview with a candidate patient.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HeartMate 3™ left ventricular assist system (HM3 LVAS)Advanced heart failure patients will be implanted with the HM3 LVAS | Device | HeartMate 3™ left ventricular assist system (HM3 LVAS) |
Primary outcome
Primary Efficacy Endpoint: Number of Participants With Overall Survival to Transplant, Myocardial Recovery or on Device Support Free of Debilitating Stroke (Modified Rankin Score >3) or Reoperation for Pump Replacement
Time frame: Up to 6 months follow-up
Overall survival to transplant, myocardial recovery or on device support free of debilitating stroke (Modified Rankin Score >3) or reoperation for pump replacement will be assessed using the Kaplan-Meier product-limit method along with a competing outcomes graph. Subjects who are urgently transplanted due to a HeartMate 3 malfunction will be considered to have experienced a primary endpoint event, as will subjects who expire, suffer a debilitating stroke or have their HeartMate 3 exchanged due to a device failure. Subjects who are transplanted (except as described above), explanted for recovery, withdraw from the trial or are lost to follow-up will be censored at that time in the analysis.
Primary Safety Endpoint: Number of Cumulative Occurrence of Adverse Events
Time frame: Up to 6 months follow-up
Cumulative occurrence of adverse events will be presented as percent of patients with adverse events
5 secondary outcomes
Mean Change in Six-minute Walk Test From Baseline
Time frame: Baseline and 1 Month post-implant
Change Proportion of New York Heart Association (NYHA) Functional Status From Baseline
Time frame: Baseline and 1 Month post-implant
Mean Change in EQ-5D-5L VAS Quality of Life (QoL) From Baseline
Time frame: Baseline and 1 Month
Frequency of Rehospitalization and Reoperation
Time frame: Up to 6 months follow-up
Number of Participants With Device Malfunctions
Time frame: Up to 6 months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Carlo Gazzola, B. Sc. study director
Abbott Medical Devices
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartMate 3™ left ventricular assist system (HM3 LVAS) in people with Advanced Heart Failure, run by Abbott Medical Devices at 3 sites in 2 countries.
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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 1 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Efficacy Endpoint: Number of Participants With Overall Survival to Transplant, Myocardial Recovery or on Device Support Free of Debilitating Stroke (Modified Rankin Score >3) or Reoperation for Pump Replacement (time frame: Up to 6 months follow-up). The study lists 2 primary outcomes in all. 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 1 Jul 2024.