MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS
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|ClinicalTrials.gov Identifier: NCT03982979|
Recruitment Status : Enrolling by invitation
First Posted : June 12, 2019
Last Update Posted : January 8, 2021
|Condition or disease||Intervention/treatment|
|Advanced Refractory Left Ventricular Heart Failure||Device: HM3 LVAS|
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if subjects receive a device exchange to any device other than HM II or HM3, at any time during the study, they will be withdrawn from the study and will not be followed.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.
|Study Type :||Observational|
|Estimated Enrollment :||533 participants|
|Official Title:||MOMENTUM 3 Pivotal Cohort Extended Follow-up Post-Approval Study|
|Actual Study Start Date :||June 20, 2019|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||March 31, 2022|
- Device: HM3 LVAS
HeartMate® 3 (HM3) Left Ventricular Assist System (LVAS)
- Survival [ Time Frame: up to 5 years post-implant ]Composite of Survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump
- Subject outcomes and survival [ Time Frame: up to 5 years post-implant ]Subject outcomes and survival which includes death, transplant, explant, or a pump exchange to any device other than HM II or HM3
- Bleeding (including GI bleeding) [ Time Frame: up to 5 years post-implant ]Frequency and incidence of bleeding (including GI bleeding)
- Major infection [ Time Frame: up to 5 years post-implant ]Frequency and incidence of major infection
- Hemolysis [ Time Frame: up to 5 years post-implant ]Frequency and incidence of hemolysis
- Device thrombosis [ Time Frame: up to 5 years post-implant ]Frequency and incidence of device thrombosis
- Neurological dysfunction [ Time Frame: up to 5 years post-implant ]Frequency and incidence of neurological dysfunction
- Device related SAEs [ Time Frame: up to 5 years post-implant ]Frequency and incidence of device related SAEs
- NYHA [ Time Frame: up to 5 years post-implant ]New York Heart Association (NYHA) classification
- 6MWD [ Time Frame: up to 5 years post-implant ]Six-minute walk distance (6MWD)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982979
|United States, Massachusetts|
|Burlington, Massachusetts, United States, 01803|
|Study Director:||Poornima Sood, MD, MBA||Abbott|