Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
109
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.
Huntsville Hospital
Huntsville, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Rate of major adverse events
Major bleeding, device-related mortality, device-related serious adverse events
Time frame: 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
Time frame: Baseline to 48 hours
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
Time frame: 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
Time frame: 30 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Emory University
Atlanta, Georgia, United States
Endeavor Health
Glenview, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Ascension St John Hospital
Detroit, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States
...and 9 more locations