Advanced Refractory Left Ventricular Heart FailureNCT03982979
MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS
An observational study of Advanced Refractory Left Ventricular Heart Failure, run by Abbott Medical Devices at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Refractory Left Ventricular Heart Failure
- What is being tested?
- HM3 LVAS
- Type of treatment
- Medical device
- How many people
- 295 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2019to 8 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MOMENTUM 3 Pivotal Cohort Extended Follow-up Post-Approval Study
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.
Read the 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.
- Being tested
- HM3 LVAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM3 LVASDevice
HeartMate® 3 (HM3) Left Ventricular Assist System (LVAS)
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Composite of Survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump
Measured: 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
Measured: up to 5 years post-implant
Bleeding (including GI bleeding)
Frequency and incidence of bleeding (including GI bleeding)
Measured: up to 5 years post-implant
Major infection
Frequency and incidence of major infection
Measured: up to 5 years post-implant
Hemolysis
Frequency and incidence of hemolysis
Measured: up to 5 years post-implant
Device thrombosis
Frequency and incidence of device thrombosis
Measured: up to 5 years post-implant
Neurological dysfunction
Frequency and incidence of neurological dysfunction
Measured: up to 5 years post-implant
Device related SAEs
Frequency and incidence of device related SAEs
Measured: up to 5 years post-implant
NYHA
New York Heart Association (NYHA) classification
Measured: up to 5 years post-implant
6MWD
Six-minute walk distance (6MWD)
Measured: up to 5 years post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start20 Jun 2019
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Refractory Left Ventricular Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marie-Elena Brett, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982979
- Sponsor's protocol ID
- ABT-CIP-10273
- Status last verified
- Jun 2022
- First submitted
- 16 May 2019
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 37612008Mehra 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.
PubMed 36074476
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOMENTUM 3 Pivotal Cohort Extended Follow-up Post-Approval Study
- ClinicalTrials.gov ID
- NCT03982979
- Acronym / sponsor ID
- ABT-CIP-10273
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Subject or legal representative does not consent to extended data collection after the MOMENTUM 3 IDE trial 2-year follow-up visit
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HM3 LVASHeartMate® 3 (HM3) Left Ventricular Assist System (LVAS) | Device | – |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Derived from this study: PubMed 37612008Nayak 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.
- Derived from this study: PubMed 36074476Mehra 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.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Refractory Left Ventricular Heart Failure
Recruiting
European Study of the BrioVAD Heart Pump for Advanced Heart Failure
Refractory Heart Failure, Cardiovascular Diseases (CVD)
Recruiting
Corheart 6 LVAS Study
Refractory Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Elena Brett, PhD study director
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Refractory Left Ventricular Heart Failure, run by Abbott Medical Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: up to 5 years post-implant). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982979, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.