SYMPHONY-PE Study for Treatment of Pulmonary Embolism
Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism
Conditions:
๐Ÿฆ  Acute Pulmonary Embolism ๐Ÿฆ  Thromboembolism ๐Ÿฆ  Emboli, Pulmonary ๐Ÿฆ  Thrombosis ๐Ÿฆ  Thrombus; Embolism ๐Ÿฆ  Embolism ๐Ÿฆ  Cardiovascular Diseases ๐Ÿฆ  Vascular Diseases
๐Ÿ—“๏ธ Study Start (Actual) 8 December 2023
๐Ÿ—“๏ธ Primary Completion (Estimated) March 2025
โœ… Study Completion (Estimated) April 2025
๐Ÿ‘ฅ Enrollment (Estimated) 150
๐Ÿ”ฌ Study Type INTERVENTIONAL
๐Ÿ“Š Phase NA
Locations:
๐Ÿ“ Huntsville, Alabama, United States
๐Ÿ“ Los Angeles, California, United States
๐Ÿ“ Tallahassee, Florida, United States
๐Ÿ“ Atlanta, Georgia, United States
๐Ÿ“ Indianapolis, Indiana, United States
๐Ÿ“ Grand Rapids, Michigan, United States
๐Ÿ“ Royal Oak, Michigan, United States
๐Ÿ“ Mount Kisco, New York, United States
๐Ÿ“ New York, New York, United States
๐Ÿ“ New York, New York, United States
๐Ÿ“ Cincinnati, Ohio, United States
๐Ÿ“ Plano, Texas, United States

๐Ÿ“‹ Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. CTA evidence of acute PE within โ‰ค14 days
    • 2. Clinical signs and symptoms consistent with acute PE.
    • 3. Systolic BP โ‰ฅ90 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/ยตL
    • 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 โ‰ฅ90 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 โ‰ค30%
    • 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).
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

๐Ÿ—“๏ธ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 September 2023
  • First Submitted that Met QC Criteria 25 September 2023
  • First Posted 2 October 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 July 2024
  • Last Update Posted 26 July 2024
  • Last Verified July 2024