MOMENTUM 3

Principal Investigator: Craig Selzman
Keywords: Heart Failure , Left Ventricular Assist Device , Cardiothoracic Surgery , Mechanical Circulatory Support , VAD Department: Cardiothoracic Division
IRB Number: 00091531 Co Investigator: Stavros Drakos
Specialty: Cardiology, Cardiothoracic Surgery, Cardiothoracic Surgery, Cardiothoracic Surgery, Cardiology, Cardiothoracic Surgery
Sub Specialties: Heart Failure, Cardiac Mechanical Support, Heart Failure, Heart Transplant, Heart Transplant
Recruitment Status: Active, not recruiting

Contact Information

Ashley Elmer
ashley.elmer@hsc.utah.edu
801-585-6775

Brief Summary

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

Study Design

The study is a prospective, multi-center, unblinded, randomized, controlled, non-inferiority study comparing the HM3 LVAS to the HM II LVAS. The FDA approved HM II will serve as the control group. Subjects will be randomized 1 HM3 to 1 HM II, total sample size = 1028. The study will be conducted as a staged pivotal study that includes a pre-specified early assessment for safety.

Other key elements include:

− Up to 5 centers in the United States (U.S.) will be initiated to enroll up to 10 randomized HM3 Subjects. A pre-specified analysis for safety will be performed after the first 10 randomized HM3 Subjects have completed 30 days of follow-up. The results of this early safety analysis will be reviewed by the Data Safety Monitoring Board (DSMB), after which the DSMB report, along with supporting safety data from the HM3 CE Mark study will be sent to FDA as an IDE supplement, with a request to gain full IDE approval to expand the study to up to a total of 60 centers in the U.S. The first 5 U.S. centers will continue to enroll up to a total of 30 subjects (including those in the early safety analysis) during FDA’s review of this IDE Supplement. (In March of 2016, the number of study sites was increased from 60 to 70)

− An adaptive design will be used, if required to adjust the sample size at a pre-specified time during the study.

 

Primary Endpoint Analysis

  • Perform an analysis and submit the Premarket Approval (PMA) when the specified number of Subjects complete 6 months of support for a short term indication

  • Perform an analysis and submit a PMA supplement when the specified number of Subjects complete 24 months of support for a long term indication

Powered Secondary Endpoint Analysis

  • Once the Subjects have been enrolled for the primary endpoint analysis, randomization will continue until sufficient Subjects have been enrolled to evaluate a pre-specified powered secondary endpoint.

  • Analysis of the pre-specified secondary endpoint will be used to update HM3 labeling.

 

The Primary study endpoints include:

1. Short Term Indication: Composite of Survival to transplant, recovery or 6 months of LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump.

2. Long Term Indication: Composite of Survival to transplant, recovery or 24 months of LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump.

 

The following secondary objectives will be evaluated:

1. Quality of Life as measured by EuroQoL 5D-5L (EQ-5D-5L) and Kansas City Cardiomyopathy Questionnaire (KCCQ)

2. Functional status as measured by the 6-minute walk test (6MWT) and NYHA classification

3. Frequency and incidence of all re-operations

4. Frequency and incidence of all rehospitalizations

5. Frequency, incidence and rates of pre-defined anticipated adverse events.

6. Frequency and incidence of device malfunctions

 

In addition to powering the study on the primary endpoints for PMA approval, the study will pre-specify a powered secondary endpoint to evaluate incidence of pump replacements at 24 months.

 

Inclusion Criteria

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

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: a) An INR ≥ 2.0 not due to anticoagulation therapy

b) Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis

c) History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 <50% predicted

d) Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention

e) History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis

f) Serum creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy

g) 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