Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
- Conditions
- Advanced Refractory Left Ventricular Heart Failure
- Interventions
- Device: HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment Arm HeartMate 3 Left Ventricular Assist System (HM3 LVAS) The treatment arm will have the HM3 LVAS implanted utilizing a technique other than full median sternotomy (e.g. thoracotomy).
- 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)
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Baptist Health Medical Center
🇺🇸Little Rock, Arkansas, United States
Spectrum Health Butterworth Hospital
🇺🇸Grand Rapids, Michigan, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
University of Coloardo Hospital
🇺🇸Aurora, Colorado, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
St. Vincent Medical Group
🇺🇸Indianapolis, Indiana, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Medical Center Fairview
🇺🇸Minneapolis, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Methodist Healthcare System of San Antonio
🇺🇸San Antonio, Texas, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Mount Sinai Hosptial
🇺🇸New York, New York, United States
New York-Presbyterian/Columbia University Medical Center
🇺🇸New York, New York, United States
Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Medical College of South Carolina
🇺🇸Charleston, South Carolina, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Shands at the University of Florida
🇺🇸Gainesville, Florida, United States
Cardiothoracic & Vascular Surgeons
🇺🇸Austin, Texas, United States