SYMPHONY-PE Study for Treatment of Pulmonary Embolism

SYMPHONY-PE is a pivotal study intended to assess the safety and efficacy of the Symphony Thrombectomy System to treat subjects with acute 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).