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出境医 / 临床实验 / MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS

MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS

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subjects receive a device exchange to any device other than HM II or HM3, at any time during the study, they will be withdrawn from the study and will not be followed.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

Study Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
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)


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 16, 2019
First Posted Date June 12, 2019
Last Update Posted Date January 8, 2021
Actual Study Start Date June 20, 2019
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2019)
  • 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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS
Official Title MOMENTUM 3 Pivotal Cohort Extended Follow-up Post-Approval Study
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Advanced Refractory Left Ventricular Heart Failure
Intervention Device: HM3 LVAS
HeartMate® 3 (HM3) Left Ventricular Assist System (LVAS)
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: June 7, 2019) 		533
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2022
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03982979
Other Study ID Numbers ABT-CIP-10273
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators
Study Director: Poornima Sood, MD, MBA Abbott
PRS Account Abbott Medical Devices
Verification Date January 2021

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