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The study will be a prospective, multi-center, non-blinded, controlled study, intended to evaluate the extended use of the HM3 LVAS compared to the HMII LVAS in those patients that are ongoing at the 2-year follow-up in the MOMENTUM 3 IDE trial. A total of 1028 subjects were enrolled in the MOMENTUM 3 IDE trial. Approximately 533 subjects were ongoing support at the 2-year follow-up and are eligible for enrollment in this PAS. This study will be conducted at sites that participated in the MOMENTUM 3 IDE trial which will include up to 69 centers in the United States.
Subjects on LVAD support after the MOMENTUM 3 IDE trial 2-year follow-up visit can be enrolled after providing consent to extended follow-up. They will be followed to 5 years post-implant or outcome (transplant, explant or death), whichever occurs first.
Subjects who have been transplanted, their device exchanged to another pump other than a HM II or HM3, or explanted after the MOMENTUM 3 IDE trial 2-year follow-up but prior to providing consent for this PAS can also be enrolled. Data between the 2-year follow-up visit and the date of pump exchange, explant, or transplant will be retrospectively collected.
Once enrolled, if subjects receive a device exchange to any device other than HM II or HM3, at any time during the study, they will be withdrawn from the study and will not be followed.
In the event that a subject expired prior to providing consent, IRB approval will be obtained to collect the date and cause of death.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM3 LVAS | Device | HeartMate® 3 (HM3) Left Ventricular Assist System (LVAS) |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Composite of Survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump | up to 5 years post-implant |
| Subject outcomes and survival | Subject outcomes and survival which includes death, transplant, explant, or a pump exchange to any device other than HM II or HM3 | up to 5 years post-implant |
| Bleeding (including GI bleeding) | Frequency and incidence of bleeding (including GI bleeding) | up to 5 years post-implant |
| Major infection | Frequency and incidence of major infection | up to 5 years post-implant |
| Hemolysis | Frequency and incidence of hemolysis | up to 5 years post-implant |
| Device thrombosis | Frequency and incidence of device thrombosis | up to 5 years post-implant |
| Neurological dysfunction | Frequency and incidence of neurological dysfunction | up to 5 years post-implant |
| Device related SAEs | Frequency and incidence of device related SAEs |
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Inclusion Criteria:
Exclusion Criteria:
Special Circumstance:
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As part of the PAS requirement, this study will consent male and female subjects with advanced refractory left ventricular heart failure who were implanted with the HM3 or HMII LVAS in the MOMENTUM 3 IDE trial and are ongoing at the 2-year follow up. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Elena Brett, PhD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott | Burlington | Massachusetts | 01803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37612008 | Derived | Nayak A, Hall SA, Uriel N, Goldstein DJ, Cleveland JC Jr, Cowger JA, Salerno CT, Naka Y, Horstmanshof D, Crandall D, Wang A, Mehra MR. Predictors of 5-Year Mortality in Patients Managed With a Magnetically Levitated Left Ventricular Assist Device. J Am Coll Cardiol. 2023 Aug 29;82(9):771-781. doi: 10.1016/j.jacc.2023.05.066. | |
| 36074476 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 7, 2022 | |
| Reset | Oct 10, 2023 | |
| Release | Jun 27, 2024 | |
| Reset | Oct 8, 2024 | |
| Release | Apr 1, 2025 | |
| Reset | Apr 18, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 7, 2022 | Oct 10, 2023 | |||
| Jun 27, 2024 |
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| up to 5 years post-implant |
| NYHA | New York Heart Association (NYHA) classification | up to 5 years post-implant |
| 6MWD | Six-minute walk distance (6MWD) | up to 5 years post-implant |
| Mehra MR, Goldstein DJ, Cleveland JC, Cowger JA, Hall S, Salerno CT, Naka Y, Horstmanshof D, Chuang J, Wang A, Uriel N. Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial. JAMA. 2022 Sep 27;328(12):1233-1242. doi: 10.1001/jama.2022.16197. |
| Oct 8, 2024 |
| Apr 1, 2025 | Apr 18, 2025 |
| Jul 6, 2026 |