Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism

Ki vehet részt

• Signed and dated informed consent form
• 18 years of age and older
• Clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days
• Diagnosis of pulmonary embolism detected from computed tomography angiography (CTA)
• Right Ventricle to Left Ventricle (RV/LV) ratio of 0.9 or higher
• Systolic blood pressure (SBP) of 90 mmHg or higher
• Heart rate of 130 beats per minute (BPM) or less prior to the procedure
• Deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment

Ki nem vehet részt

• Has had a cardiovascular or pulmonary surgery within the past 7 days of index procedure
• Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• Has pulmonary hypertension with peak pulmonary artery pressure (PAP) > 70 mmHg
• Presence of cancer requiring active chemotherapy
• Known bleeding diathesis or coagulation disorder
• Platelets count < 100,000/µL
• Serum creatinine >1.8 mg/dL
• International Normalized Ratio (INR) > 3
• History of severe or chronic pulmonary hypertension, uncompensated heart failure, chest irradiation, underlying lung disease that is oxygen dependent, Heparin-induced thrombocytopenia (HIT) and/or chronic left heart disease with left ventricular ejection fraction ≤ 30%
• Excluded from the study if he/she meets any of the following exclusion criteria
• May be pregnant as determined by a positive pregnancy test or who are breastfeeding
• Has any contraindication to systemic or therapeutic doses of heparin or anticoagulants
• Has used thrombolytics (tPA) in the past 30 days of baseline CTA
• Fraction of inspired oxygen (FiO2) requirement >40% or >6 liters per minute (LPM) to keep oxygen saturations >90%
• Hematocrit <28% within 6 hours of the index procedure
• Has undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) > 15
• Requires Vasopressor after fluids to keep pressure ≥ 90 mmHg
• With left bundle branch block
• Has intracardiac lead in the right ventricle or atrium
• Evidence such as imaging or other that suggests the subject is not appropriate for this procedure
• Has life expectancy < 90 days
• Dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO)
• Participation in another investigational study