SYMPHONY-PE Study for Treatment of Pulmonary Embolism

Exclusion Criteria

• •1. Thrombolytic use within 14 days of baseline CTA
• •2. International Normalized Ratio (INR) \>3
• •3. Platelets \<100,000/µL
• •4. Kidney dysfunction as confirmed by serum creatinine \>1.8 mg/dL or GFR \<45 mL/min
• •5. Hematocrit \<28% or hemoglobin \<9 g/dL
• •6. Systolic BP \<90 mmHg for 15 min or requirement of inotropic support to maintain systolic BP ≥90 mmHg any time after admission
• •7. Experienced cardiac arrest
• •8. Has left bundle branch block
• •9. Known bleeding diathesis or coagulation disorder
• •10. Presence of intracardiac lead in the right ventricle or right atrium
• •11. Presence of intracardiac thrombus
• •12. Major trauma within the past 14 days
• •13. Cardiovascular or pulmonary surgery within last 7 days
• •14. Known serious, uncontrolled sensitivity to radiographic agents
• •15. Contraindication to anticoagulants, i.e., heparin or alternative
• •16. Patient on extracorporeal membrane oxygenation (ECMO)
• •17. Cancer requiring active chemotherapy
• •18. Heparin-induced thrombocytopenia (HIT)
• •19. Pulmonary hypertension with peak pulmonary artery pressure \>70 mmHg by right heart catheterization.
• •20. History of chronic severe pulmonary hypertension, and/or chronic left heart disease with left ventricular ejection fraction ≤30%
• •21. Life expectancy \<90 days as determined by investigator
• •22. Pregnant or nursing
• •23. COVID-19 positive at hospital admission
• •24. Current participation in another investigational study
• •25. Evidence such as imaging or other that suggests the subject is not appropriate for this procedure (e.g., target vessel size is too small to accommodate 16F or 24F catheters).