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History of Changes for Study: NCT02475460
HeartMate 3™ LIS Study (HM 3 LIS)
Latest version (submitted June 23, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 17, 2015 None (earliest Version on record)
2 January 4, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 March 30, 2016 Study Status and Conditions
4 April 8, 2016 Study Status and Study Identification
5 July 20, 2016 Recruitment Status and Study Status
6 January 28, 2019 Sponsor/Collaborators, Study Status, Contacts/Locations and Study Identification
7 June 23, 2022 Contacts/Locations and Study Status
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Study NCT02475460
Submitted Date:  June 17, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: HeartMate 3 LIS
Brief Title: HeartMate 3™ LIS Study (HM 3 LIS)
Official Title: Thoratec Corporation HeartMate 3™ Less Invasive Surgery (LIS) Study
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2015
Overall Status: Recruiting
Study Start: May 2015
Primary Completion: December 2015 [Anticipated]
Study Completion: June 2016 [Anticipated]
First Submitted: June 11, 2015
First Submitted that
Met QC Criteria:
June 17, 2015
First Posted: June 18, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 17, 2015
Last Update Posted: June 18, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Thoratec Corporation
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Heart Failure
Cardiovascular Disease
Keywords: HeartMate 3
LVAS
LVAD
Heart-assist Devices
Advanced
Ventricular Dysfunction
refractory left ventricular
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 13 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of survival participants
[ Time Frame: 30 days ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Laura Damme, BSN, MPH
Email: laura.damme@thoratec.com
Study Officials: Laura Damme, BSN, MPH
Study Director
Thoratec Corporation
Locations: Czech Republic
Institute for Clinical and Experimental Medicine (IKEM)
[Recruiting]
Prague, Czech Republic, 4
Contact:Contact: Jana Turkova jana.turkova@ikem.cz
Contact:Principal Investigator: Ivan Netuka, MD, PhD
Germany
Deutsches Herzzentrum Berlin
[Not yet recruiting]
Berlin, Germany, 13353
Contact:Contact: Sabine Huebler shuebler@dhzb.de
Contact:Principal Investigator: Thomas Krabatsch, MD, PhD
Medizinische Hochschule Hannover
[Not yet recruiting]
Hannover, Germany, 30625
Contact:Contact: Kirsten Stelter stelter.kirsten@mh-hannover.de
Contact:Principal Investigator: Jan Schmitto, MD, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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