The investigation is intended to evaluate the safety and effectiveness of the AlphaReturn Blood Management System when used in conjunction with the cleared AlphaVac MMA F1885 System for the treatment of acute pulmonary embolism.
This is a prospective, multicenter, single-arm investigational device study evaluating safety and effectiveness.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
The AlphaReturn Blood Management System allows for autologous injection of aspirated blood from an AlphaVac MMA System thrombectomy procedure.
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States
RECRUITINGUniversity at Buffalo
Buffalo, New York, United States
RECRUITINGJacobi Medical Center
The Bronx, New York, United States
Rate of Device-Related Adverse Events (AEs)
The number and proportion of subjects who experienced at least one device-related adverse event. This will be summarized, and the 95% confidence interval of the proportion will be presented. The incidence of device-related adverse events by type and seriousness through 30 days will also be summarized.
Time frame: Through 30 days post-procedure
Rate of Technical Success
Successful autologous blood transfusion using the AlphaReturn Blood Management System
Time frame: Periprocedural
Rate of Major Adverse Events (MAEs)
The rate of MAEs within the first 48 hours after the index procedure. MAEs include device-related death, major bleeding, and device-related SAEs of clinical deterioration, pulmonary vascular injury, and cardiac injury.
Time frame: Through 48 hours post-procedure
Rate of Complications
Rate of complications including device-related clinical deterioration, device-related cardiac injury, device-related pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure.
Time frame: Through 48 hours post-procedure
Rate of Device-Related SAEs
Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post procedure.
Time frame: Through 30 days post-procedure
Rate of Symptomatic PE recurrence within 30 days
Symptomatic PE recurrence within 30 days.
Time frame: Through 30 days post-procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kettering Health
Kettering, Ohio, United States
RECRUITINGBaylor Heart Hospital Plano
Plano, Texas, United States
RECRUITINGMethodist Healthcare
San Antonio, Texas, United States
RECRUITINGReduction in RV/LV Ratio
Reduction in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.
Time frame: Through 48 hours post-procedure
Thrombolytics Use
Use of thrombolytics during or within 48 hours of the procedure.
Time frame: Through 48 hours post-procedure
Length of Stay in Intensive Care Unit
Length of stay in the Intensive Care Unit (ICU) within 30 days post-procedure.
Time frame: Through 30 days post-procedure
Length of Stay in Hospital
Length of stay in the hospital within 30 days post-procedure.
Time frame: Through 30 days post-procedure