|Principal Investigator: Craig Selzman|
|Keywords: Heart Failure , Left Ventricular Assist Device , Cardiothoracic Surgery , Mechanical Circulatory Support , VAD||Department: Cardiothoracic Division|
|IRB Number: 00096851||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: Completed|
The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the MOMENTUM 3 IDE Study.
The study will be a single-arm, prospective, multi-center, study for continued evaluation of safety and clinical performance of the HM3 LVAS.
All endpoints will be descriptively compared to the arms of the MOMENTUM 3 IDE.
1. Composite of Survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score >3) or reoperation to replace the pump at 6 and 24 months
2. Quality of Life as measured by EuroQoL 5D-5L (EQ-5D-5L) and Kansas City Cardiomyopathy Questionnaire (KCCQ)
3. Functional status as measured by the 6-minute walk test (6MWT) and NYHA classification
4. Frequency and incidence of all re-operations
5. Frequency and incidence of all rehospitalizations
6. Frequency, incidence and rates of pre-defined anticipated adverse events
7. Frequency and incidence of device malfunctions
8. Frequency and incidence of pump replacement
9. Overall survival
Total sample size for the CAP = 1500
The Sponsor anticipated an approximate 12-month gap between the end of enrollment in the MOMENTUM 3 trial and the FDA decision on the PMA submitted in support of a short-term indication for use. The MOMENTUM 3 CAP was initiated to bridge this gap, allowing investigators to maintain proficiency with the HM3 device while the FDA reviews the ST PMA. Enrollment in the CAP began on August 31, 2016 and was completed in May 2017, prior to an FDA decision on the ST PMA. As such, the CAP was extended to allow an additional 500 subjects.
The Sponsor anticipates that the FDA will approve the ST PMA prior to enrolling all of the additional 500 patients into the CAP study, but continued access will still be needed for long-term (e.g. Destination Therapy) patients pending submission and review of the PMA supplement for that indication for use. Immediately upon FDA approval of the PMA for the ST indication for use, the Sponsor will notify investigators that, going forward, they should not enroll any additional patients meeting the approved indication for use (e.g. bridge to transplant patients).
On October 20, 2017 FDA approved a second extension to the MOMENTUM 3 CAP study to increase the max enrollment by an additional 500 subjects. The study may now enroll up to a max number of 1500 subjects at 69 centers. This increase in max subjects is considered an administrative change, and thus the CAP protocol was not amended. Finally, a third CAP extension for a total of 2000 subjects was approved in July 2018.
Approval for the long-term indication was received from the FDA on October 18, 2018. Sites were notified on October 19, 2018 that CAP enrollment was ending. The last implant in CAP occurred on October 25, 2018 for a total enrollment of 1685 patients. As a condition of approval, all patients enrolled in the CAP study will complete the 24 month follow-up specified in this protocol to fulfill a post-approval study (PAS) requirement.
All Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.
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
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
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
19) Patients actively listed for heart transplant (this exclusion applies only after commercial approval of the HM3 for short-term use)