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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
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Condition or disease Intervention/treatment
Advanced Refractory Left Ventricular Heart Failure Device: HM3 LVAS

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subjects receive a device exchange to any device other than HM II or HM3, at any time during the study, they will be withdrawn from the study and will not be followed.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

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Study Type : Observational
Estimated Enrollment : 533 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • Device: HM3 LVAS
    HeartMate® 3 (HM3) Left Ventricular Assist System (LVAS)


Primary Outcome Measures :
  1. 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

  2. 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

  3. Bleeding (including GI bleeding) [ Time Frame: up to 5 years post-implant ]
    Frequency and incidence of bleeding (including GI bleeding)

  4. Major infection [ Time Frame: up to 5 years post-implant ]
    Frequency and incidence of major infection

  5. Hemolysis [ Time Frame: up to 5 years post-implant ]
    Frequency and incidence of hemolysis

  6. Device thrombosis [ Time Frame: up to 5 years post-implant ]
    Frequency and incidence of device thrombosis

  7. Neurological dysfunction [ Time Frame: up to 5 years post-implant ]
    Frequency and incidence of neurological dysfunction

  8. Device related SAEs [ Time Frame: up to 5 years post-implant ]
    Frequency and incidence of device related SAEs

  9. NYHA [ Time Frame: up to 5 years post-implant ]
    New York Heart Association (NYHA) classification

  10. 6MWD [ Time Frame: up to 5 years post-implant ]
    Six-minute walk distance (6MWD)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Abbott
Burlington, Massachusetts, United States, 01803
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Poornima Sood, MD, MBA Abbott
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03982979    
Other Study ID Numbers: ABT-CIP-10273
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases