SYMPHONY-PE Study for Treatment of Pulmonary Embolism

August 6, 2026 updated by: Imperative Care, Inc.

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

Intervention / Treatment

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)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 48 hours
A composite of all-cause major bleeding, device-related mortality, device-related serious adverse events
48 hours
Mean Reduction of RV/LV Ratio
Time Frame: 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
Baseline to 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Safety Endpoints: 48 Hours
Time Frame: 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
48 Hours
Secondary Safety Endpoints: 30 Days
Time Frame: 30 Days
Evaluate rates of PE related mortality, All-cause mortality, Device-related SAEs and Symptomatic PE recurrence
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperative Care, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 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)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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