An observational study in Advanced Refractory Left Ventricular Heart Failure, sponsored by Abbott Medical Devices. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-06-24.
Sponsored by Abbott Medical Devices · Observational
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if subjects receive a device exchange to any device other than HM II or HM3, at any time during the study, they will be withdrawn from the study and will not be followed.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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 295 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Special Circumstance:
HeartMate® 3 (HM3) Left Ventricular Assist System (LVAS)
Survival
Composite of Survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score \> 3) or reoperation to replace the pump
Time frame: 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
Time frame: up to 5 years post-implant
Bleeding (including GI bleeding)
Frequency and incidence of bleeding (including GI bleeding)
Time frame: up to 5 years post-implant
Major infection
Frequency and incidence of major infection
Time frame: up to 5 years post-implant
Hemolysis
Frequency and incidence of hemolysis
Time frame: up to 5 years post-implant
Device thrombosis
Frequency and incidence of device thrombosis
Time frame: up to 5 years post-implant
Neurological dysfunction
Frequency and incidence of neurological dysfunction
Time frame: up to 5 years post-implant
Device related SAEs
Frequency and incidence of device related SAEs
Time frame: up to 5 years post-implant
NYHA
New York Heart Association (NYHA) classification
Time frame: up to 5 years post-implant
6MWD
Six-minute walk distance (6MWD)
Time frame: up to 5 years post-implant
Plan to share: Undecided
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Abbott Medical Devices