N/A
Completed N=1,028
MOMENTUM 3 IDE Clinical Study Protocol
Advanced Refractory Left Ventricular Heart Failure
Source: ClinicalTrials.gov NCT02224755 ↗
Enrolled (actual)
1,028
Serious AEs
93.0%
Results posted
Nov 2019
Primary outcomePrimary: Short Term Primary End Point — 109; 131 Participants — p=<0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short Term Primary End Point |
109; 131 | <0.001 sig |
| PRIMARY Long Term Primary End Point |
106; 151 | <0.001 sig |
| SECONDARY Powered Secondary End Point: Pump Replacement at Two Years |
57; 12 | <0.001 sig |
| SECONDARY EuroQoL 5D-5L (EQ-5D-5L) Total Score |
11.2; 11.1; 8.5; 8.5; 9.2; 8.8 | — |
| SECONDARY EuroQol-5D-5L Visual Analogue Scale |
48; 50; 74; 76; 75; 76 | — |
| SECONDARY Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score |
40; 39; 70; 70; 68; 69 | — |
| SECONDARY Six Minute Walk Test |
129; 136; 327; 310; 361; 323 | — |
| SECONDARY New York Heart Association (NYHA) Classification |
0; 0; 310; 340; 176; 219 | — |
| SECONDARY Rehospitalizations |
2.47; 2.26 | — |
| SECONDARY Adverse Event Rates |
0.02; 0.01; 0.95; 0.61; 0.45; 0.37 | — |
Eligibility Criteria
Inclusion Criteria
- Subject or legal representative has signed Informed Consent Form (ICF)
- Age ≥ 18 years
- BSA ≥ 1.2 m2
- NYHA Class III with dyspnea upon mild physical activity, or NYHA Class IV
- LVEF ≤ 25%
- a) Inotrope dependent OR b) CI 5 cm in diameter within 6 months of enrollment
- Presence of an active, uncontrolled infection
- Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy 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 ≥ 2.0 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 80%) uncorrected carotid stenosis
- Serum creatinine ≥ 221 umol/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
- Patient has moderate to severe aortic insufficiency without plans for correction during pump implant
- 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)
- Planned Bi-VAD support prior to enrollment
- Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
- 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 24 months
Data sourced from ClinicalTrials.gov (NCT02224755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.