Acute Pulmonary Embolism, Cardiovascular Diseases, Emboli, Pulmonary, Embolism, Thromboembolism, Thrombosis, Thrombus; Embolism, Vascular Diseases
Conditions
Keywords
Thrombectomy, Submassive Pulmonary Embolism, Right Ventricle dysfunction
Brief summary
Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism
Detailed description
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.
Interventions
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.
Sponsors
Imperative Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. CTA evidence of acute PE within ≤14 days 2. Clinical signs and symptoms consistent with acute PE. 3. 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) 4. Stable heart rate \<130 BPM prior to procedure 5. Subject is between 18 and 80 years of age 6. Subject is willing to sign an IRB-approved informed consent form 7. Subject is willing and able to comply with protocol follow-up
Exclusion criteria
1. Thrombolytic use within 14 days of baseline CTA 2. International Normalized Ratio (INR) \>3 3. Platelets \<100,000/µL 4. Kidney dysfunction as confirmed by serum creatinine \>1.8 mg/dL or GFR \<45 mL/min 5. Hematocrit \<28% or hemoglobin \<9 g/dL 6. Systolic BP \<90 mmHg for 15 min or requirement of inotropic support to maintain systolic BP ≥90 mmHg any time after admission 7. Experienced cardiac arrest 8. Has left bundle branch block 9. Known bleeding diathesis or coagulation disorder 10. Presence of intracardiac lead in the right ventricle or right atrium 11. Presence of intracardiac thrombus 12. Major trauma within the past 14 days 13. Cardiovascular or pulmonary surgery within last 7 days 14. Known serious, uncontrolled sensitivity to radiographic agents 15. Contraindication to anticoagulants, i.e., heparin or alternative 16. Patient on extracorporeal membrane oxygenation (ECMO) 17. Cancer requiring active chemotherapy 18. Heparin-induced thrombocytopenia (HIT) 19. Pulmonary hypertension with peak pulmonary artery pressure \>70 mmHg by right heart catheterization. 20. History of chronic severe pulmonary hypertension, and/or chronic left heart disease with left ventricular ejection fraction ≤30% 21. Life expectancy \<90 days as determined by investigator 22. Pregnant or nursing 23. COVID-19 positive at hospital admission 24. Current participation in another investigational study 25. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Events | 48 hours | A composite of all-cause major bleeding, device-related mortality, device-related serious adverse events |
| Mean Reduction of RV/LV Ratio | Baseline to 48 hours | Change in RV/LV ratio from baseline to 48 hours post procedure assessed by CT Angiography (CTA) and adjudicated by an independent core-lab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Endpoints: 48 Hours | 48 Hours | Evaluate rates of all-cause major bleeding, device-related mortality, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury |
| Secondary Safety Endpoints: 30 Days | 30 Days | Evaluate rates of PE related mortality, All-cause mortality, Device-related SAEs and Symptomatic PE recurrence |
Countries
United States
Participant flow
Recruitment details
A total of 684 patients were screened, 110 consented and 109 subjects enrolled across 17 centers in the United States.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| History of deep vein thrombosis | 41 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 71 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 109 |
| other Total, other adverse events | 25 / 109 |
| serious Total, serious adverse events | 12 / 109 |
Outcome results
None listed