SYMPHONY-PE Study for Treatment of Pulmonary Embolism

Not Applicable

Active, not recruiting

• Conditions: Acute Pulmonary Embolism; Thrombosis; Thromboembolism; Emboli, Pulmonary; Thrombus; Embolism; Embolism; Cardiovascular Diseases; Vascular Diseases
• Interventions: Device: Symphony Thrombectomy System

• Registration Number: NCT06062329
• Lead Sponsor: Imperative Care, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-10-02
• Study Start: 2023-12-08
• Status Verified: 2025-05
• Primary Completion: 2025-05-02
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 109

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Symphony Thrombectomy system	Symphony Thrombectomy System	Mechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

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

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