MOMENTUM 3 IDE Clinical Study Protocol (HM3™)

Abbott

Status: Completed

Conditions: Advanced Refractory Left Ventricular Heart Failure

Treatments: Device: HeartMate II LVAS; Device: HeartMate 3 LVAS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02224755

TC03062014

Details and patient eligibility

About

The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.

Full description

The HM3 LVAS is intended to provide hemodynamic support in patients with advanced, refractory left ventricular heart failure; either for short term support, such as a bridge to cardiac transplantation (BTT) or myocardial recovery, or as long term support, such as destination therapy (DT). The HM3 is intended for use inside or outside the hospital.

Enrollment: 1,028 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject or legal representative has signed Informed Consent Form (ICF)

2. Age ≥ 18 years

3. BSA ≥ 1.2 m2

4. NYHA Class III with dyspnea upon mild physical activity, or NYHA Class IV

5. LVEF ≤ 25%

6. a) Inotrope dependent OR b) CI < 2.2 L/min/m2, while not on inotropes and subjects 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
   • Advanced Heart Failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) for at least 7 days

7. 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. Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant

6. History of any organ transplant

7. Platelet count < 100,000 x 103/L (< 100,000/ml)

8. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management

9. History of confirmed, untreated AAA > 5 cm in diameter within 6 months of enrollment

10. Presence of an active, uncontrolled infection

11. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status

12. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:

    1. An INR ≥ 2.0 not due to anticoagulation therapy
    2. Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
    3. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 <50% predicted
    4. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
    5. History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis
    6. Serum creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy
    7. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration

13. Patient has moderate to severe aortic insufficiency without plans for correction during pump implant

14. Pre albumin < 150 mg/L (15mg/dL) or Albumin < 30g/L (3 g/dL) (if only one available) ; pre albumin < 150 mg/L (15mg/dL) and Albumin < 30g/L (3 g/dL) (if both available)

15. Planned Bi-VAD support prior to enrollment

16. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia

17. Participation in any other clinical investigation that is likely to confound study results or affect the study

18. Any condition other than HF that could limit survival to less than 24 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,028 participants in 2 patient groups

HeartMate 3 LVAS (HM3 LVAS)

Experimental group

Description:

Evaluation of the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.

Treatment:

Device: HeartMate 3 LVAS

HeartMate II LVAS

Active Comparator group

Description:

Evaluation of the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.

Treatment:

Device: HeartMate II LVAS