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
1 other identifier
interventional
109
1 country
19
Brief Summary
Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2023
CompletedFirst Posted
Study publicly available on registry
October 2, 2023
CompletedStudy Start
First participant enrolled
December 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2025
CompletedJuly 15, 2025
July 1, 2025
1.4 years
September 25, 2023
July 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
30 Days
Study Arms (1)
Symphony Thrombectomy system
EXPERIMENTALMechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism.
Interventions
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.
Eligibility Criteria
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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Huntsville Hospital
Huntsville, Alabama, 35801, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
Emory University
Atlanta, Georgia, 30322, United States
Endeavor Health
Glenview, Illinois, 60026, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Ascension St John Hospital
Detroit, Michigan, 48236, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073, United States
Northwell Health
Mount Kisco, New York, 10549, United States
NYU Grossman School of Medicine
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Bon Secours Mercy Health, Inc
Cincinnati, Ohio, 45237, United States
Prisma Health
Greenville, South Carolina, 29605, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Medical City Fort Worth Hospital
Fort Worth, Texas, 76104, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Related Publications (1)
Bangalore S, Tomalty RD, Kado H, Sayfo S, Raskin A, Qamar A, Vargas Estrada A, Garcia-Reyes K, Lipshutz HG, Yallapragada S, Butty S, Gandhi S, Dexter D, Trivax J, Ali F, Knox M, Ramos C, Al-Saghir Y, Bishay V. Prospective Multicenter IDE Study of the Next-Generation Precision Aspiration Thrombectomy System for Intermediate-Risk Pulmonary Embolism: The SYMPHONY-PE Trial. Circ Cardiovasc Interv. 2025 Nov;18(11):e015815. doi: 10.1161/CIRCINTERVENTIONS.125.015815. Epub 2025 Sep 17.
PMID: 40961960DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2023
First Posted
October 2, 2023
Study Start
December 13, 2023
Primary Completion
May 4, 2025
Study Completion
May 29, 2025
Last Updated
July 15, 2025
Record last verified: 2025-07