Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
109 participants
INTERVENTIONAL
2023-12-13
2025-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Symphony Thrombectomy system
Mechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism.
Symphony Thrombectomy System
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.
Interventions
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Symphony Thrombectomy System
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.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
80 Years
ALL
No
Sponsors
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Imperative Care, Inc.
INDUSTRY
Responsible Party
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Locations
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Huntsville Hospital
Huntsville, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
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
Northwell Health
Mount Kisco, New York, United States
NYU Grossman School of Medicine
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Bon Secours Mercy Health, Inc
Cincinnati, Ohio, United States
Prisma Health
Greenville, South Carolina, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Medical City Fort Worth Hospital
Fort Worth, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Countries
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References
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Bangalore S, Tomalty RD, Kado H, Sayfo S, Raskin A, Qamar A, Vargas Estrada A, Garcia-Reyes K, Lipshutz HG, Yallapragada S, Butty S, Gandhi S, Dexter D, Trivax J, Ali F, Knox M, Ramos C, Al-Saghir Y, Bishay V. Prospective Multicenter IDE Study of the Next-Generation Precision Aspiration Thrombectomy System for Intermediate-Risk Pulmonary Embolism: The SYMPHONY-PE Trial. Circ Cardiovasc Interv. 2025 Sep 17:e015815. doi: 10.1161/CIRCINTERVENTIONS.125.015815. Online ahead of print.
Other Identifiers
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TRU-2023-001
Identifier Type: -
Identifier Source: org_study_id
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