HeartMate 3™ LIS Study

Heart Failure Clinical Trial

— HM 3 LIS  

Official title:

Thoratec Corporation HeartMate 3™ Less Invasive Surgery (LIS) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475460
• Other study ID #: HeartMate 3 LIS
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: July 2016

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Heart Failure

Intervention

Procedure:
• Less Invasive Surgery (LIS)
Less invasive HM 3 LVAD surgical implant procedure

Device:
• HeartMate 3™
HM 3 LIS

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine (IKEM)	Prague
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Medizinische Hochschule Hannover	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Thoratec Corporation

Countries where clinical trial is conducted

Czechia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of survival participants		30 days