SYMPHONY-PE Study for Treatment of Pulmonary Embolism

Completed · Not applicable

Conditions studied: Acute Pulmonary Embolism, Thromboembolism, Emboli, Pulmonary, Thrombosis, Thrombus; Embolism, Embolism, Cardiovascular Diseases, Vascular Diseases

In brief

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

Key facts

Study ID: NCT06062329
Run by: Imperative Care, Inc.
People needed: 109
Starts: 2023-12-13
Expected to finish: 2025-05-29
Last updated by the study team: 2025-07-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

CTA evidence of acute PE within ≤14 days
Clinical signs and symptoms consistent with acute PE.
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)
Stable heart rate <130 BPM prior to procedure
Subject is between 18 and 80 years of age
Subject is willing to sign an IRB-approved informed consent form
Subject is willing and able to comply with protocol follow-up

You may not qualify if…

Thrombolytic use within 14 days of baseline CTA
International Normalized Ratio (INR) >3
Platelets <100,000/µL
Kidney dysfunction as confirmed by serum creatinine >1.8 mg/dL or GFR <45 mL/min
Hematocrit <28% or hemoglobin <9 g/dL
Systolic BP <90 mmHg for 15 min or requirement of inotropic support to maintain systolic BP ≥90 mmHg any time after admission
Experienced cardiac arrest
Has left bundle branch block
Known bleeding diathesis or coagulation disorder
Presence of intracardiac lead in the right ventricle or right atrium
Presence of intracardiac thrombus
Major trauma within the past 14 days
Cardiovascular or pulmonary surgery within last 7 days
Known serious, uncontrolled sensitivity to radiographic agents
Contraindication to anticoagulants, i.e., heparin or alternative
Patient on extracorporeal membrane oxygenation (ECMO)
Cancer requiring active chemotherapy
Heparin-induced thrombocytopenia (HIT)
Pulmonary hypertension with peak pulmonary artery pressure >70 mmHg by right heart catheterization.
History of chronic severe pulmonary hypertension, and/or chronic left heart disease with left ventricular ejection fraction ≤30%
Life expectancy <90 days as determined by investigator
Pregnant or nursing
COVID-19 positive at hospital admission
Current participation in another investigational study
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).

Where it is running

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

Full record on ClinicalTrials.gov

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