Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
295 participants
OBSERVATIONAL
2019-06-20
2021-09-08
Brief Summary
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Detailed Description
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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if subjects receive a device exchange to any device other than HM II or HM3, at any time during the study, they will be withdrawn from the study and will not be followed.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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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HM3 LVAS
HeartMate® 3 (HM3) Left Ventricular Assist System (LVAS)
Eligibility Criteria
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Inclusion Criteria
* Subject was enrolled in the MOMENTUM 3 IDE trial and was ongoing at the 2-year follow-up visit
Exclusion Criteria
Special Circumstance:
* Sites with patients who expired after the MOMENTUM 3 IDE trial 2-year follow-up visit but prior to signing the ICF for this PAS will obtain IRB approval to collect only the date and cause of death
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Marie-Elena Brett, PhD
Role: STUDY_DIRECTOR
Abbott
Locations
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Abbott
Burlington, Massachusetts, United States
Countries
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References
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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.
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.
Other Identifiers
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ABT-CIP-10273
Identifier Type: -
Identifier Source: org_study_id
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