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NCT03982979 · ClinicalTrials.gov registry record
MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 295
- Enrollment target
NCT03982979: Completed study, sponsored by Abbott Medical Devices.
NCT03982979 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 295 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03982979 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 295 participants
- Enrollment target
Study 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.
Primary Outcome
Composite of Survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score \> 3) or reoperation to replace the pump
Interventions
- DEVICE HM3 LVAS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 295 participants |
| Start Date | 2019-06-20 |
| Est. Completion | 2021-09-08 |
What the finished NCT03982979 record still lists
NCT03982979 is an observational study that tracks outcomes without assigning an intervention. The registered 295 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which HM3 LVAS is the first listed.
NCT03982979 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03982979 about?
NCT03982979 is a clinical study titled "MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS". 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...
What is the current status of trial NCT03982979?
This trial is currently completed. The enrollment target is 295 participants. The study started on 2019-06-20. Estimated completion is 2021-09-08.
What interventions are being tested in trial NCT03982979?
The interventions under investigation include: HM3 LVAS (DEVICE).
Who is sponsoring clinical trial NCT03982979?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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