DuoCor 2 DOMINATE Study

Korábbi kezelés

• 1. Known intolerance to anticoagulant or antiplatelet therapies.
• 4. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.

Más betegség

• 2. Etiology of heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis /senile or other infiltrative heart disease).
• 9. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
• History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 < 50% predicted.
• Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration;
• 10. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units.
• 12. Blood stream infection within seven days. Positive blood cultures reflective of contaminants (e.g., Staphylococcus epidermidis) will not be considered an exclusion.
• 14. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
• 15. Any condition other than HF that could limit survival to less than 24 months.

Laborértékek

• 3. Coagulopathy defined by platelets < 100k/µl or INR ≥ 1.5 not due to anticoagulant therapy.
• Total bilirubin > 3.0 mg/dL or cirrhosis confirmed by imaging or positive biopsy;
• Glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 or renal replacement therapy dependence;

Egyéb

• 5. Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days.
• 6. Presence of ECMO with a duration greater than 10 days.
• 7. Patient is implanted with durable mechanical circulatory support (LVAD or RVAD) and has refused to switch to the study device.
• 8. Patient experienced cerebrovascular accident (CVA) within 3 months of eligibility evaluation.
• 11. Severe systemic light-chain amyloidosis.
• 13. Sepsis
• 16. Positive pregnancy test if of childbearing potential.
• 17. Lactating mothers.
• 18. Participation in any other clinical investigation that is likely to confound study results or affect the study.

• 1. Age ≥ 18 years and ≤ 75 years
• 2. Patient is inotrope dependent, OR has a Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes
• 3. Patient has left heart failure with at least one of the following criteria:
• Left ventricular ejection fiction (LVEF) ≤ 30%;
• Pulmonary capillary wedge pressure (PCWP) > 15mmHg.
• 4. Patient has severe, irreversible biventricular heart failure and is eligible for biventricular mechanical circulatory support based on the ISHLT guideline. This includes at least two of the following hemodynamic and/or echocardiographic measurements:
• Right ventricular ejection fraction (RVEF)≤ 30%;
• Right ventricular stroke work index (RVSWI)≤ 0.25 mmHg*L/m2;
• Tricuspid annular plane systolic excursion (TAPSE)≤ 14 mm;
• Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio> 0.72;
• Central venous pressure (CVP)> 15 mmHg;
• CVP to PCWP ratio> 0.63;
• Tricuspid insufficiency grade 2-4;
• Pulmonary artery pressure index (PAPi)< 2;
• 5. Patient or its legal representative has signed the informed consent, has full understanding of procedures and the study, and is committed to following study requirements.