Loading clinical trials...

SYMPHONY-PE Study for Treatment of Pulmonary Embolism | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT06062329•Imperative Care, Inc.

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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
+15 more criteria

Locations (19)

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

Key Dates

Start Date

December 13, 2023

Primary Completion Date

May 4, 2025

Completion Date

May 29, 2025

Last Updated

July 15, 2025

Enrollment

109

ACTUAL participants

Conditions

Acute Pulmonary EmbolismThromboembolismEmboli, PulmonaryThrombosisThrombus; EmbolismEmbolismCardiovascular DiseasesVascular Diseases

Interventions

Symphony Thrombectomy System

DEVICE

CLEANer Aspiration for Pulmonary Embolism

NCT06189313

Pulmonary EmbolismAcute Pulmonary Embolism+2 more

View study

RECRUITINGPHASE3

REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults

NCT07015905

Venous Thromboembolism (VTE)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

SYMPHONY-PE Study for Treatment of Pulmonary Embolism

Inclusion Criteria

Exclusion Criteria

CLEANer Aspiration for Pulmonary Embolism

REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults

Computerized Decision Support for Prevention of VTE in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT)

AI-driven Clinical Decision Support to Reduce Hospital-Acquired Venous Thromboembolism: Study Protocol for the VTE-AI Randomized Trial.

Low INR to Minimize Bleeding With Mechanical Valves Trial

External Validation of the CLOVER Score for Detecting Occult Cancer in Venous Thromboembolism Patients