We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

HeartMate 3™ LIS Study (HM 3 LIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02475460
Recruitment Status : Completed
First Posted : June 18, 2015
Last Update Posted : June 24, 2022
Sponsor:
Collaborator:
Thoratec Corporation
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.

Condition or disease Intervention/treatment Phase
Heart Failure Cardiovascular Disease Procedure: Less Invasive Surgery (LIS) Device: HeartMate 3™ Not Applicable

Detailed Description:
This study will evaluate the less invasive implantation technique of the HM 3 LVAS.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Thoratec Corporation HeartMate 3™ Less Invasive Surgery (LIS) Study
Study Start Date : May 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: HM 3 LIS
All patients implanted with the HM 3 LVAD via less invasive surgical technique
Procedure: Less Invasive Surgery (LIS)
Less invasive HM 3 LVAD surgical implant procedure

Device: HeartMate 3™
HM 3 LIS




Primary Outcome Measures :
  1. Number of survival participants [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient or legal representative has signed Informed Consent Form (ICF)
  2. Age ≥ 18 years
  3. BSA ≥ 1.2 m2
  4. NYHA IIIB or IV, or ACC/AHA Stage D
  5. LVEF ≤ 25%
  6. CI ≤ 2.2 L/min/m2, while not on inotropes (if Patient is treated with inotropes at baseline, this does not apply)
  7. Patients must also meet one of the following:

    • On optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond, OR
    • In NYHA class IIIB or IV heart failure for at least 14 days AND dependent on intraaortic balloon pump (IABP) for at least 7 days, OR
    • Inotrope dependent/unable to wean from inotropes OR
    • Listed for transplant
  8. Females of child bearing age must agree to use adequate contraception-

Exclusion Criteria:

  1. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
  2. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the Investigator
  3. Existence of ongoing mechanical circulatory support (MCS) other than IABP
  4. Positive pregnancy test if of childbearing potential
  5. Lactating mothers
  6. Presence of mechanical aortic cardiac valve
  7. History of any organ transplant
  8. Platelet count < 100,000 x 103/L (< 100,000/ml)
  9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
  10. History of confirmed, untreated AAA > 5 cm in diameter
  11. Presence of an active, uncontrolled infection
  12. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy that the Investigator will require based upon the patients' health status
  13. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:

    • An INR ≥ 2.5 not due to anticoagulation therapy
    • Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
    • History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 <50% predicted
    • Fixed pulmonary hypertension with a 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%) carotid artery stenosis
    • Serum Creatinine ≥ 221umol/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
  14. Aortic valve regurgitation > grade 1
  15. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL)
  16. Planned Bi-VAD support prior to enrollment
  17. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
  18. Planned concomitant intra-cardiac cardiac surgery
  19. Thrombus formation in the atrium or left ventricle identified by echocardiogram
  20. Previous sternotomy or left-sided thoracotomy
  21. Participation in any other clinical investigation that is likely to confound study results or affect the study
  22. Any condition other than HF that could limit survival to less than 6 months

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): NCT02475460


Locations
Layout table for location information
Czechia
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia, 4
Germany
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Sponsors and Collaborators
Abbott Medical Devices
Thoratec Corporation
Investigators
Layout table for investigator information
Study Director: Sami Somo Abbott
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02475460    
Other Study ID Numbers: HeartMate 3 LIS
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Keywords provided by Abbott Medical Devices:
HeartMate 3
LVAS
LVAD
Heart-assist Devices
Advanced
Ventricular Dysfunction
refractory left ventricular
Thoratec Corporation
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases