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

This is a prospective, multicenter, single-arm investigational device study evaluating safety and effectiveness.

Inclusion criteria

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.

Exclusion criteria

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 used thrombolytics in the 30 days prior to the baseline CTA.
• Subjects who have pulmonary hypertension with peak pulmonary artery pressure (PAP) > 70 mmHg.
• 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 with platelets count < 100,000/μL.
• Subjects with serum creatinine > 1.8 mg/dL.
• Subjects with International Normalized Ratio (INR) > 3.
• Subjects who have undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) > 15.
• Subjects with the presence of cancer requiring active chemotherapy.
• Subjects with known bleeding diathesis or coagulation disorder.
• Subjects who have had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.
• 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%.
• Subjects with known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.
• 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.