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

Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Refractory Left Ventricular Heart Failure
• Intervention / Treatment: Device: HeartMate 3 Left Ventricular Assist System (HM3 LVAS)

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Medical Center
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Coloardo Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • Shands at the University of Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Medical Group
  • Kansas
    • Kansas City, Kansas, United States, 66106
      • Kansas University Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Butterworth Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center Fairview
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New York
    • New York, New York, United States, 10032
      • New York-Presbyterian/Columbia University Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai Hosptial
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical College of South Carolina
  • Texas
    • Austin, Texas, United States, 78756
      • Cardiothoracic & Vascular Surgeons
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center at Dallas
    • San Antonio, Texas, United States, 78201
      • Methodist Healthcare System of San Antonio
  • Washington
    • Spokane, Washington, United States, 99202
      • Sacred Heart Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects from the general heart failure population.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Arm; The treatment arm will have the HM3 LVAS implanted utilizing a technique other than full median sternotomy (e.g. thoracotomy).	Device: HeartMate 3 Left Ventricular Assist System (HM3 LVAS); This clinical trial investigates implant of the HM3 LVAS by techniques other than full median sternotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Mean length of hospital stay from implant to hospital discharge	Initial hospital stay, approximately 3 weeks

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Sami Somo, PhD, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Actual): July 19, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ABT-CIP-10335VerC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No