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

Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Vascular Diseases; Embolism; Thrombosis; Thromboembolism; Acute Pulmonary Embolism; Thrombus; Embolism; Emboli, Pulmonary
• Intervention / Treatment: Device: Symphony Thrombectomy System

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.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Huntsville Hospital
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32256
      • First Coast Cardiovascular Institute
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Endeavor Health
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Michigan
    • Detroit, Michigan, United States, 48236
      • Ascension St John Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Corewell Health
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital - Royal Oak
  • New York
    • Mount Kisco, New York, United States, 10549
      • Northwell Health
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10016
      • NYU Grossman School of Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45237
      • Bon Secours Mercy Health, Inc
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health
  • Texas
    • Dallas, Texas, United States, 75230
      • Medical City Dallas Hospital
    • Fort Worth, Texas, United States, 76104
      • Medical City Fort Worth Hospital
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Symphony Thrombectomy system; Mechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of major adverse events	Major bleeding, device-related mortality, device-related serious adverse events	48 hours
Mean reduction of RV/LV ratio	Change in RV/LV ratio from baseline to post procedure assessed by CT Angiography and adjudicated by an independent Core-lab	Baseline to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of Major bleeding, device-related mortality, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury	Evaluate rates of major bleeding, device-related mortality, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury	48 Hours
Rates of PE related mortality, all-cause mortality, device-related SAEs and symptomatic PE recurrence	Evaluate rates of PE related mortality, All-cause mortality, Device-related SAEs and Symptomatic PE recurrence	30 Days

Collaborators and Investigators

• Sponsor: Imperative Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Actual): May 4, 2025
• Study Completion (Actual): May 29, 2025

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Thrombectomy; Submassive Pulmonary Embolism; Right Ventricle dysfunction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Cardiovascular Diseases; Pulmonary Embolism; Thrombosis; Vascular Diseases; Embolism; Thromboembolism
• Other Study ID Numbers: TRU-2023-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No