Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS

Completed

• Conditions: Advanced Refractory Left Ventricular Heart Failure

• Registration Number: NCT04548128
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-14
• Study Start: 2020-11-17
• Primary Completion: 2022-07-19
• Study Completion: 2022-12-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
Length of Stay	Initial hospital stay, approximately 3 weeks	Mean length of hospital stay from implant to hospital discharge

Trial Locations

Locations (32)

Baptist Health Medical Center; 🇺🇸 Little Rock, Arkansas, United States

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

University of Coloardo Hospital; 🇺🇸 Aurora, Colorado, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Shands at the University of Florida; 🇺🇸 Gainesville, Florida, United States

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

St. Vincent Medical Group; 🇺🇸 Indianapolis, Indiana, United States

Kansas University Medical Center; 🇺🇸 Kansas City, Kansas, United States

Scroll for more (22 remaining)