Evaluating the Efficacy, Safety and Long Term Functional Outcomes of Percutaneous Mechanical Aspiration Thrombectomy for Treatment of Acute Pulmonary Embolism Using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Trial Parameters
Brief Summary
To evaluate the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute pulmonary embolism.
Eligibility Criteria
Inclusion Criteria: * Symptomatic, CTPA-proven acute PE with a maximum duration of symptoms of 14 days, showing a filling defect in at least one main or proximal lobar pulmonary artery * RV/LV diameter ratio ≥ 1.0 assessed by CTPA * Serum troponin levels above upper limit of normal as per hospital policy * ≥ 18 years of age * At least one of the following: 1. Electrocardiogram (ECG)-documented tachycardia with heart rate ≥ 100 BPM, not due to hypovolemia, arrhythmia or sepsis 2. Systolic blood pressure ≤ 110mmHg for at least 15 minutes 3. Respiratory rate \> 20 breaths per minuted. Oxygen saturation on pulse oximetry (SpO2) \< 90% (or partial arterial oxygen pressure \< 60 mmHg) at rest while breathing room air 4. Known history of heart failure * Willing and able to provide written informed consent prior to receiving study specific procedures. Exclusion Criteria: * A contraindication to therapeutic anticoagulation * Any comorbid diagnosis consistent with a life expectancy of less than