SYMPHONY-PE Study for Treatment of Pulmonary Embolism

Study Overview
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Brief Summary
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Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism

Detailed Description
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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.

Official Title
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Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism

Conditions
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Acute Pulmonary Embolism, Thromboembolism, Emboli, Pulmonary, Thrombosis, Thrombus; Embolism, Embolism, Cardiovascular Diseases, Vascular Diseases

Intervention / Treatment
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* Device: Symphony Thrombectomy System


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symphony Thrombectomy system<br>Mechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism. | Device: Symphony Thrombectomy System<br>* The Symphony Thrombectomy System will be used to restore blood flow to the pulmonary arteries by removing thrombus/embolus/clot using aspiration and mechanical clot engagement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major adverse events | Major bleeding, device-related mortality, device-related serious adverse events | 48 hours | 
| Mean reduction of RV/LV ratio | Change in RV/LV ratio from baseline to post procedure assessed by CT Angiography and adjudicated by an independent Core-lab | Baseline to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Major bleeding, device-related mortality, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury | Evaluate rates of major bleeding, device-related mortality, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury | 48 Hours | 
| Rates of PE related mortality, all-cause mortality, device-related SAEs and symptomatic PE recurrence | Evaluate rates of PE related mortality, All-cause mortality, Device-related SAEs and Symptomatic PE recurrence | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombectomy, Submassive Pulmonary Embolism, Right Ventricle dysfunction