Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
NCT ID: NCT04548128
Last Updated: 2023-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
102 participants
OBSERVATIONAL
2020-11-17
2022-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Treatment Arm
The treatment arm will have the HM3 LVAS implanted utilizing a technique other than full median sternotomy (e.g. thoracotomy).
HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
This clinical trial investigates implant of the HM3 LVAS by techniques other than full median sternotomy.
Interventions
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HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
This clinical trial investigates implant of the HM3 LVAS by techniques other than full median sternotomy.
Eligibility Criteria
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Inclusion Criteria
2. Subject must be ≥ 18 years of age at the time of informed consent
3. Subject is receiving the HM3 as their first LVAD
4. Body surface area (BSA) ≥ 1.2m2
5. Subject is NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV
6. LVEF ≤ 25%
7. Subject is:
1. Inotrope dependent OR
2. Has CI\<2.2 L/min/m2, while not on inotropes and meets one of the following criteria:
* On optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond to therapy
* Advanced heart failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) for at least 7 days
8. Females of child bearing age must agree to use adequate contraception
Exclusion Criteria
2. Subject has greater than mild aortic insufficiency
3. Physiologically significant (i.e. requires intervention) atrial septal defect
4. Subject has severe right heart failure (RHF) (refer to Appendix 2 for guidance)
5. Subject has planned Bi-VAD support prior to enrollment
6. Presence of mechanical aortic valve that will not be either converted to bioprosthesis or oversewn at the time of LVAD implant
7. Subject has ongoing mechanical circulatory support (MCS) at the time of LVAD surgery other than IABP
8. Subject has a history of any organ transplant
9. Positive pregnancy test
10. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
11. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
12. Platelet count \< 100,000 x 103/L (\< 100,000/ml)
13. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
14. History of confirmed, untreated AAA \> 5 cm in diameter within 6 months of enrollment
15. Presence of an active, uncontrolled infection
16. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the subjects' health status
17. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
1. An INR ≥ 2.0 not due to anticoagulation therapy
2. Total bilirubin \> 43 μmol/L (2.5 mg/dl) or biopsy-proven liver cirrhosis
3. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC \< 0.7, and FEV1 \<50% predicted
4. Fixed pulmonary hypertension with most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
5. History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (\> 80%) uncorrected carotid stenosis
6. Serum creatinine ≥ 221 μmol/L (2.5 mg/dl) or the need for chronic renal replacement therapy
7. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration
18. Pre-albumin \< 150mg/liter (15 mg/dl) or albumin \<30 g/liter (3g/dl) (if only one available); pre-albumin \<150mg/liter (15 mg/dl) and albumin \<30 g/liter (3 g/dl) (if both available)
19. Subject has known hypo- or hyper-coagulable states such as disseminated intravascular coagulation and heparin-induced thrombocytopenia
20. Participation in any other clinical investigation that is likely to confound study results or affect the study
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Sami Somo, PhD
Role: STUDY_DIRECTOR
Abbott
Locations
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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 D.C., 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
Ochsner Medical Center
New Orleans, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Mount Sinai Hosptial
New York, New York, United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, 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
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical College of South Carolina
Charleston, South Carolina, United States
Cardiothoracic & Vascular Surgeons
Austin, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States
Sacred Heart Medical Center
Spokane, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Foothills Medical Centre
Calgary, Alberta, Canada
Countries
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Other Identifiers
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ABT-CIP-10335VerC
Identifier Type: -
Identifier Source: org_study_id
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