HeartMate 3™ LIS Study (HM 3 LIS)

Abbott

Status

Completed

Conditions

Heart Failure

Cardiovascular Disease

Treatments

Device: HeartMate 3™

Procedure: Less Invasive Surgery (LIS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02475460

HeartMate 3 LIS

Details and patient eligibility

About

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.

Full description

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

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient or legal representative has signed Informed Consent Form (ICF)
Age ≥ 18 years
BSA ≥ 1.2 m2
NYHA IIIB or IV, or ACC/AHA Stage D
LVEF ≤ 25%
CI ≤ 2.2 L/min/m2, while not on inotropes (if Patient is treated with inotropes at baseline, this does not apply)
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
Females of child bearing age must agree to use adequate contraception-

Exclusion criteria

Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
Technical obstacles which pose an inordinately high surgical risk, in the judgment of the Investigator
Existence of ongoing mechanical circulatory support (MCS) other than IABP
Positive pregnancy test if of childbearing potential
Lactating mothers
Presence of mechanical aortic cardiac valve
History of any organ transplant
Platelet count < 100,000 x 103/L (< 100,000/ml)
Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
History of confirmed, untreated AAA > 5 cm in diameter
Presence of an active, uncontrolled infection
Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy that the Investigator will require based upon the patients' health status
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
Aortic valve regurgitation > grade 1
Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL)
Planned Bi-VAD support prior to enrollment
Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
Planned concomitant intra-cardiac cardiac surgery
Thrombus formation in the atrium or left ventricle identified by echocardiogram
Previous sternotomy or left-sided thoracotomy
Participation in any other clinical investigation that is likely to confound study results or affect the study
Any condition other than HF that could limit survival to less than 6 months