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

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ClinicalTrials.gov Identifier: NCT04548128
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Advanced Refractory Left Ventricular Heart Failure Device: HeartMate 3 Left Ventricular Assist System (HM3 LVAS)

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy
Actual Study Start Date : November 17, 2020
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.




Primary Outcome Measures :
  1. 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. [ Time Frame: 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 :
  1. Length of Stay [ Time Frame: Initial hospital stay, approximately 3 weeks ]
    Mean length of hospital stay from implant to hospital discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects from the general heart failure population.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548128


Contacts
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Contact: Jody Oyama, DrPH 971-329-5422 jody.oyama@Abbott.com

Locations
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Sponsors and Collaborators
Abbott Medical Devices
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04548128    
Other Study ID Numbers: ABT-CIP-10335VerB
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases