MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS
Completed
Conditions studied: Advanced Refractory Left Ventricular Heart Failure
In brief
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.
Key facts
- Study ID
- NCT03982979
- Run by
- Abbott Medical Devices
- People needed
- 295
- Starts
- 2019-06-20
- Expected to finish
- 2021-09-08
- Last updated by the study team
- 2022-06-24
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Abbott — Burlington, Massachusetts, United States
Full record on ClinicalTrials.gov
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