Clinical trial NCT04548128: Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
Official title: Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Refractory Left Ventricular Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2020-09-14
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects from the general heart failure population.

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.


Eligibility criteria: Inclusion Criteria

1. Subject or Legal Representative has provided written informed consent by signing the study Informed Consent Form (ICF)
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

1. Subject has a planned concomitant procedure at time of implant (e.g. valve repair, CABG, ASD repair, etc)
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

Primary outcomes:
measure: 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.
timeFrame: 6 Months
Secondary outcomes:
measure: Length of Stay
timeFrame: Initial hospital stay, approximately 3 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Baptist Health Medical Center
state: Arkansas
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: University of Coloardo Hospital
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: Shands at the University of Florida
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Medical Group
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health Butterworth Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Mount Sinai Hosptial
state: New York
city: New York
country: United States
facility: New York-Presbyterian/Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical College of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Cardiothoracic & Vascular Surgeons
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare System of San Antonio
state: Texas
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
affiliation: Abbott
name: Sami Somo, PhD
role: STUDY_DIRECTOR
References: