Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS (SWIFT)
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|ClinicalTrials.gov Identifier: NCT04548128|
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 8, 2021
|Condition or disease||Intervention/treatment|
|Advanced Refractory Left Ventricular Heart Failure||Device: HeartMate 3 Left Ventricular Assist System (HM3 LVAS)|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy|
|Actual Study Start Date :||November 17, 2020|
|Estimated Primary Completion Date :||May 30, 2022|
|Estimated Study Completion Date :||May 30, 2022|
The treatment arm will have the HM3 LVAS implanted utilizing a technique other than full median sternotomy (e.g. thoracotomy).
Device: HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
This clinical trial investigates implant of the HM3 LVAS by techniques other than full median sternotomy.
- Proportion of patients surviving 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. [ Time Frame: 6 Months ]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.
- Length of Stay [ Time Frame: Initial hospital stay, approximately 3 weeks ]Mean length of hospital stay from implant to hospital discharge
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548128
|Contact: Jody Oyama, DrPH||971-329-5422||jody.oyama@Abbott.com|