Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness

Ki vehet részt

• A potential subject will be included in the study if he/she meets all the following inclusion criteria:
• Provision of signed and dated informed consent form
• Subject is 18 years of age and older
• Subject presents clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days
• Subject has a diagnosis of pulmonary embolism detected from computed tomography angiography (CTA)
• Subject has a RV/LV ratio of 0.9 or higher
• Subject has a systolic blood pressure (SBP) of 90mmHg or higher
• Subject has a heart rate of 130 beats per minute (BPM) or less prior to the procedure
• Subject is deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment

Ki nem vehet részt

• Subjects who have used thrombolytics in the 30 days prior to the baseline CTA
• Subjects who have had a cardiovascular or pulmonary surgery within the past 7 days of index procedure
• Subjects with known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• Subjects who have pulmonary hypertension with peak pulmonary artery pressure (PAP) > 70 mmHg
• Subjects with the presence of cancer requiring active chemotherapy
• Subjects with known bleeding diathesis or coagulation disorder
• Subjects with platelets count < 100,000/μL
• Subjects with serum creatinine > 1.8 mg/dL
• Subjects with International Normalized Ratio (INR) > 3
• Subjects with a 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%
• A potential subject will be excluded from the study if he/she meets any of the following exclusion criteria:
• Subjects who are or may be pregnant as determined by a positive pregnancy test or who are breastfeeding
• Subjects who have any contraindication to systemic or therapeutic doses of heparin or anticoagulants
• Subjects who have FiO2 requirement > 44% or > 6 LPM to keep oxygen saturations > 90%
• Subjects with hematocrit < 28% within 6 hours of index procedure
• Subjects who have undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) > 15
• Subject requires vasopressor after fluids to keep pressure ≥ 90mmHg
• Subjects with left bundle branch block
• Subjects who have intracardiac lead in the right ventricle or atrium
• Evidence such as imaging or other that suggest the subject is not appropriate for this procedure
• Subjects that have life expectancy < 90 days, in the opinion of the investigator at the time of enrollment
• Subjects dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO)
• Participation in another investigational study