Status:
COMPLETED
SYMPHONY-PE Study for Treatment of Pulmonary Embolism
Lead Sponsor:
Imperative Care, Inc.
Conditions:
Acute Pulmonary Embolism
Thromboembolism
Eligibility:
All Genders
18-80 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2025
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT06062329
Start Date
December 13 2023
End Date
May 29 2025
Last Update
July 15 2025
Active Locations (19)
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1
Huntsville Hospital
Huntsville, Alabama, United States, 35801
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
First Coast Cardiovascular Institute
Jacksonville, Florida, United States, 32256
4
Tallahassee Memorial Hospital
Tallahassee, Florida, United States, 32308