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

Completed

Conditions studied: Advanced Refractory Left Ventricular Heart Failure

In brief

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.

Key facts

Study ID: NCT04548128
Run by: Abbott Medical Devices
People needed: 102
Starts: 2020-11-17
Expected to finish: 2022-12-20
Last updated by the study team: 2023-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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
Females of child bearing age must agree to use adequate contraception

You may not qualify if…

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
Physiologically significant (i.e. requires intervention) atrial septal defect
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
Subject has ongoing mechanical circulatory support (MCS) at the time of LVAD surgery other than IABP
Subject has a history of any organ transplant
Positive pregnancy test
Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
Platelet count < 100,000 x 103/L (< 100,000/ml)
Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
History of confirmed, untreated AAA > 5 cm in diameter within 6 months of enrollment
Presence of an active, uncontrolled infection
Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the subjects' health status
Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
An INR ≥ 2.0 not due to anticoagulation therapy
Total bilirubin > 43 μmol/L (2.5 mg/dl) or biopsy-proven liver cirrhosis
History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 <50% predicted
Fixed pulmonary hypertension with most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis
Serum creatinine ≥ 221 μmol/L (2.5 mg/dl) or the need for chronic renal replacement therapy
Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration
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)

Where it is running

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

Full record on ClinicalTrials.gov

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