SYMPHONY-PE Study for Treatment of Pulmonary Embolism

Inclusion Criteria:

1. CTA evidence of acute PE within ≤14 days

2. Clinical signs and symptoms consistent with acute PE.

3. Systolic BP ≥90 mmHg with evidence of dilated RV with an RV/LV ratio >0.9 (based onInvestigator's assessment of RV/LV ratio)

4. Stable heart rate <130 BPM prior to procedure

5. Subject is between 18 and 80 years of age

6. Subject is willing to sign an IRB-approved informed consent form

7. Subject is willing and able to comply with protocol follow-up

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 maintainsystolic 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 heartcatheterization.

20. History of chronic severe pulmonary hypertension, and/or chronic left heart diseasewith 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 forthis procedure (e.g., target vessel size is too small to accommodate 16F or 24Fcatheters).