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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

Tracking Information
First Submitted Date  ICMJE June 11, 2015
First Posted Date  ICMJE June 18, 2015
Last Update Posted Date June 24, 2022
Study Start Date  ICMJE May 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2015)
Number of survival participants [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HeartMate 3™ LIS Study
Official Title  ICMJE Thoratec Corporation HeartMate 3™ Less Invasive Surgery (LIS) Study
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.
Detailed Description This study will evaluate the less invasive implantation technique of the HM 3 LVAS.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Heart Failure
  • Cardiovascular Disease
Intervention  ICMJE
  • Procedure: Less Invasive Surgery (LIS)
    Less invasive HM 3 LVAD surgical implant procedure
  • Device: HeartMate 3™
    HM 3 LIS
Study Arms  ICMJE Experimental: HM 3 LIS
All patients implanted with the HM 3 LVAD via less invasive surgical technique
Interventions:
  • Procedure: Less Invasive Surgery (LIS)
  • Device: HeartMate 3™
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2015)
13
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Germany
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02475460
Other Study ID Numbers  ICMJE HeartMate 3 LIS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Abbott Medical Devices
Original Responsible Party Thoratec Corporation
Current Study Sponsor  ICMJE Abbott Medical Devices
Original Study Sponsor  ICMJE Thoratec Corporation
Collaborators  ICMJE Thoratec Corporation
Investigators  ICMJE
Study Director: Sami Somo Abbott
PRS Account Abbott Medical Devices
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP