Clinical trial NCT03982979: MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS
Official title: MOMENTUM 3 Pivotal Cohort Extended Follow-up Post-Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Refractory Left Ventricular Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-06-12
Enrollment: 295
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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if subjects receive a device exchange to any device other than HM II or HM3, at any time during the study, they will be withdrawn from the study and will not be followed.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.

Eligibility criteria: Inclusion Criteria:

* Subject or legal representative has signed Informed Consent Form (ICF)
* Subject was enrolled in the MOMENTUM 3 IDE trial and was ongoing at the 2-year follow-up visit

Exclusion Criteria:

* Subject or legal representative does not consent to extended data collection after the MOMENTUM 3 IDE trial 2-year follow-up visit

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

Primary outcomes:
measure: Survival
timeFrame: up to 5 years post-implant
measure: Subject outcomes and survival
timeFrame: up to 5 years post-implant
measure: Bleeding (including GI bleeding)
timeFrame: up to 5 years post-implant
measure: Major infection
timeFrame: up to 5 years post-implant
measure: Hemolysis
timeFrame: up to 5 years post-implant
measure: Device thrombosis
timeFrame: up to 5 years post-implant
measure: Neurological dysfunction
timeFrame: up to 5 years post-implant
measure: Device related SAEs
timeFrame: up to 5 years post-implant
measure: NYHA
timeFrame: up to 5 years post-implant
measure: 6MWD
timeFrame: up to 5 years post-implant
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Abbott
state: Massachusetts
Study officials:
affiliation: Abbott
name: Marie-Elena Brett, PhD
role: STUDY_DIRECTOR
References:
citation: 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.