Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Advanced Refractory Left Ventricular Heart Failure
- Sponsor
- Abbott Medical Devices
- Enrollment
- 102
- Locations
- 32
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Length of Stay(Initial hospital stay, approximately 3 weeks)