MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS

NCT03982979 | Completed DMC FDA Device

• 1 other identifier: ABT-CIP-10273
• Study Type: observational
• Target: 295
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Refractory Left Ventricular Heart Failure

Outcome Measures

Primary Outcomes (10)

• 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

  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

Interventions

HM3 LVAS DEVICE

HeartMate® 3 (HM3) Left Ventricular Assist System (LVAS)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott

Burlington, Massachusetts, 01803, United States

Location

Related Publications (2)

• 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.

  PMID: 37612008 DERIVED

• 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.

  PMID: 36074476 DERIVED

Study Officials

• Marie-Elena Brett, PhD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: June 12, 2019
• Study Start: June 20, 2019
• Primary Completion: September 8, 2021
• Study Completion: September 8, 2021
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

US (1)