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NCT04548128 · ClinicalTrials.gov registry record
Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 102
- Enrollment target
NCT04548128: Completed study, sponsored by Abbott Medical Devices.
NCT04548128 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 102 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04548128 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 102 participants
- Enrollment target
Study Summary
This is a prospective, post-market, multi-center, non-blinded, single arm study of the HeartMate 3 Left Ventricular Assist System (LVAS). The objective of this study is to evaluate the implantation of the HM3 utilizing techniques other than full median sternotomy (e.g. thoracotomy) and impact on post-implant length of stay.
Primary Outcome
The composite primary endpoint of the study is survival at 6 months free of debilitating stroke (Modified Rankin Score \> 3), device malfunction requiring re-operation to replace or remove the device, or conversion of the implant surgical approach to open sternotomy.
Interventions
- DEVICE HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2020-11-17 |
| Est. Completion | 2022-12-20 |
What the finished NCT04548128 record still lists
NCT04548128 is an observational study that tracks outcomes without assigning an intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which HeartMate 3 Left Ventricular Assist System (HM3 LVAS) is the first listed.
NCT04548128 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04548128 about?
NCT04548128 is a clinical study titled "Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS". This is a prospective, post-market, multi-center, non-blinded, single arm study of the HeartMate 3 Left Ventricular Assist System (LVAS). The objective of this study is to evaluate the implantation of the HM3 utilizing techniques other than full median sternotomy (e.g. thoracotomy) and impact on pos...
What is the current status of trial NCT04548128?
This trial is currently completed. The enrollment target is 102 participants. The study started on 2020-11-17. Estimated completion is 2022-12-20.
What interventions are being tested in trial NCT04548128?
The interventions under investigation include: HeartMate 3 Left Ventricular Assist System (HM3 LVAS) (DEVICE).
Who is sponsoring clinical trial NCT04548128?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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