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| ID | Type | Description | Link |
|---|---|---|---|
| CRD 1022 | Other Identifier | Other Study ID Number |
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Low enrollment and regulatory status change
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeartMate 3™ left ventricular assist system (HM3 LVAS) | Experimental | Patients will be implanted with the HM3 LVAS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartMate 3™ left ventricular assist system (HM3 LVAS) | Device | Advanced heart failure patients will be implanted with the HM3 LVAS |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Up to 6 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 1 Month post-implant |
| Change Proportion of New York Heart Association (NYHA) Functional Status From Baseline |
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Inclusion Criteria:
- 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.
Exclusion Criteria: None
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| Name | Affiliation | Role |
|---|---|---|
| Carlo Gazzola, B. Sc. | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hong Kong | Hong Kong | Pokfulam | Hong Kong | |||
| National Taiwan University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) | Patients will be implanted with the HM3 LVAS HeartMate 3™ left ventricular assist system (HM3 LVAS): Advanced heart failure patients will be implanted with the HM3 LVAS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) | Patients will be implanted with the HM3 LVAS HeartMate 3™ left ventricular assist system (HM3 LVAS): Advanced heart failure patients will be implanted with the HM3 LVAS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 6 months follow-up |
|
Adverse events were collected from baseline until study early termination. One subjects was followed until 6 months follow-up, while two reached 3 months visits
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) | Patients implanted with the HeartMate 3™ left ventricular assist system (HM3 LVAS) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrhythmias | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
The trial has been prematurely ended. Three 3 subjects were enrolled of which 2 have reached their 3 months follow-up and 1 reached 6 months at the time of study interruption.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlo Gazzola | Abbott | +3227746811 | carlo.gazzola@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 2, 2020 | Feb 10, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2021 | Feb 10, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 8, 2020 | Apr 15, 2024 | ICF_003.pdf |
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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. |
| 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. | Baseline and 1 Month |
| Frequency of Rehospitalization and Reoperation | Frequency and reason will be reported for rehospitalization and reoperation. | Up to 6 months follow-up |
| Number of Participants With Device Malfunctions | All suspected HM3 device malfunctions will be reported. | Up to 6 months follow-up |
| Taipei |
| 100 |
| Taiwan |
| Tri-Service General Hospital | Taipei | 114 | Taiwan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| NYHA | 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 | Count of Participants | Participants |
|
| INTERMACS | INTERMACS Profiles describe the Heart Failure stage of the patients
| Count of Participants | Participants |
|
| Indication | Count of Participants | Participants |
|
| LVEF | Mean | Full Range | percentage of LVEF |
|
Patients will be implanted with the HM3 LVAS HeartMate 3™ left ventricular assist system (HM3 LVAS): Advanced heart failure patients will be implanted with the HM3 LVAS |
|
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| Primary | 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 | Posted | Count of Participants | Participants | Up to 6 months follow-up |
|
|
|
| Secondary | 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. | Three subjects performed the assessment at Baseline and 1-Month, while two performed at 3 Months and one at 6 months (study premature end) | Posted | Mean | Standard Deviation | meters | Baseline and 1 Month post-implant |
|
|
|
| Secondary | 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. | Three subjects performed the assessment at Baseline and 1-Month, while two performed at 3 Months and one at 6 months (study premature end) | Posted | Mean | Standard Deviation | Unit on a scale | Baseline and 1 Month post-implant |
|
|
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| Secondary | 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. | Three subjects performed the assessment at Baseline and 1-Month, while two performed at 3 Months and one at 6 months (study premature end) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 Month |
|
|
|
| Secondary | Frequency of Rehospitalization and Reoperation | Frequency and reason will be reported for rehospitalization and reoperation. | Posted | Number | number of events | Up to 6 months follow-up |
|
|
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| Secondary | Number of Participants With Device Malfunctions | All suspected HM3 device malfunctions will be reported. | Posted | Number | number of patients | Up to 6 months follow-up |
|
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|
| 0 |
| 3 |
| 1 |
| 3 |
| 1 |
| 3 |
| Neurological dysfunctions | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
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