SYMPHONY-PE Study for Treatment of Pulmonary Embolism

Inclusion Criteria: CTA evidence of acute PE within ≤14 days Clinical signs and symptoms consistent with acute PE. Systolic BP ≥90 mmHg with evidence of dilated RV with an RV/LV ratio >0.9 (based on Investigator's assessment of RV/LV ratio) Stable heart rate <130 BPM prior to procedure Subject is between 18 and 80 years of age Subject is willing to sign an IRB-approved informed consent form Subject is willing and able to comply with protocol follow-up Exclusion Criteria: Thrombolytic use within 14 days of baseline CTA International Normalized Ratio (INR) >3 Platelets <100,000/µL Kidney dysfunction as confirmed by serum creatinine >1.8 mg/dL or GFR <45 mL/min Hematocrit <28% or hemoglobin <9 g/dL Systolic BP <90 mmHg for 15 min or requirement of inotropic support to maintain systolic BP ≥90 mmHg any time after admission Experienced cardiac arrest Has left bundle branch block Known bleeding diathesis or coagulation disorder Presence of intracardiac lead in the right ventricle or right atrium Presence of intracardiac thrombus Major trauma within the past 14 days Cardiovascular or pulmonary surgery within last 7 days Known serious, uncontrolled sensitivity to radiographic agents Contraindication to anticoagulants, i.e., heparin or alternative Patient on extracorporeal membrane oxygenation (ECMO) Cancer requiring active chemotherapy Heparin-induced thrombocytopenia (HIT) Pulmonary hypertension with peak pulmonary artery pressure >70 mmHg by right heart catheterization. History of chronic severe pulmonary hypertension, and/or chronic left heart disease with left ventricular ejection fraction ≤30% Life expectancy <90 days as determined by investigator Pregnant or nursing COVID-19 positive at hospital admission Current participation in another investigational study 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).