Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS (NCT04548128) | Clinical Trial Compass
CompletedNot Applicable
Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
United States102 participantsStarted 2020-11-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject or Legal Representative has provided written informed consent by signing the study Informed Consent Form (ICF)
✓. Subject must be ≥ 18 years of age at the time of informed consent
✓. Subject is receiving the HM3 as their first LVAD
✓. Body surface area (BSA) ≥ 1.2m2
✓. Subject is NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV
✓. LVEF ≤ 25%
✓. Subject is:
✓. Inotrope dependent OR
Exclusion criteria
✕. Subject has a planned concomitant procedure at time of implant (e.g. valve repair, CABG, ASD repair, etc)
✕. Subject has greater than mild aortic insufficiency
✕. Subject has severe right heart failure (RHF) (refer to Appendix 2 for guidance)
✕. Subject has planned Bi-VAD support prior to enrollment
✕. Presence of mechanical aortic valve that will not be either converted to bioprosthesis or oversewn at the time of LVAD implant
What they're measuring
1
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.