Acute Pulmonary EmbolismNCT06062329
SYMPHONY-PE Study for Treatment of Pulmonary Embolism
A study testing Symphony Thrombectomy System in people with Acute Pulmonary Embolism and Thromboembolism, run by Imperative Care, Inc. at 19 sites in United States.
Trial summary
Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pulmonary Embolism, Thromboembolism, Emboli, Pulmonary
- What is being tested?
- Symphony Thrombectomy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 19 sitesUnited States
- Study dates
- 13 Dec 2023to 29 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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).
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Emory University
Atlanta, Georgia, 30322
Bon Secours Mercy Health, Inc
Cincinnati, Ohio, 45237
Medical City Dallas Hospital
Dallas, Texas, 75230
Ascension St John Hospital
Detroit, Michigan, 48236
Medical City Fort Worth Hospital
Fort Worth, Texas, 76104
Endeavor Health
Glenview, Illinois, 60026
Corewell Health
Grand Rapids, Michigan, 49503
Prisma Health
Greenville, South Carolina, 29605
Huntsville Hospital
Huntsville, Alabama, 35801
Indiana University
Indianapolis, Indiana, 46202
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Northwell Health
Mount Kisco, New York, 10549
NYU Grossman School of Medicine
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
The Heart Hospital Baylor Plano
Plano, Texas, 75093
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
About this study
Official title: 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
Read the 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.
- Conditions
- Acute Pulmonary Embolism, Thromboembolism, Emboli, Pulmonary, Thrombosis, Thrombus; Embolism, Embolism
- Being tested
- Symphony Thrombectomy System
- Keywords
- Thrombectomy, Submassive Pulmonary Embolism, Right Ventricle dysfunction
- Medical subject headings
- Thromboembolism, Pulmonary Embolism, Thrombosis, Embolism, Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symphony Thrombectomy SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Symphony Thrombectomy system | Experimental | Mechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism. Receives: Device: Symphony Thrombectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Adverse Events
A composite of all-cause major bleeding, device-related mortality, device-related serious adverse events
Measured: 48 hours
Mean Reduction of RV/LV Ratio
Change in RV/LV ratio from baseline to 48 hours post procedure assessed by CT Angiography (CTA) and adjudicated by an independent core-lab
Measured: Baseline to 48 hours
Secondary outcomes (2)
Secondary Safety Endpoints: 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
Measured: 48 Hours
Secondary Safety Endpoints: 30 Days
Evaluate rates of PE related mortality, All-cause mortality, Device-related SAEs and Symptomatic PE recurrence
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start13 Dec 2023
- Primary completion4 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperative Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062329
- Sponsor's protocol ID
- TRU-2023-001
- Status last verified
- Jul 2025
- First submitted
- 25 Sep 2023
- Last updated
- 10 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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. Is There a Golden Hour for Thrombectomy in Intermediate-Risk Pulmonary Embolism? Insights From SYMPHONY-PE. Circ Cardiovasc Interv. 2026 Jun 18:e016573. doi: 10.1161/CIRCINTERVENTIONS.126.016573. Online ahead of print.
PubMed 42312382Bangalore 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.
PubMed 40961960
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT06062329
- Acronym / sponsor ID
- TRU-2023-001
- Conditions
- Acute Pulmonary Embolism, Thromboembolism, Emboli, Pulmonary, Thrombosis, Thrombus; Embolism, Embolism
- Keywords
- Thrombectomy, Submassive Pulmonary Embolism, Right Ventricle dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Imperative Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 4 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Posted 10 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symphony Thrombectomy system | Experimental | Device: Symphony Thrombectomy SystemMechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symphony Thrombectomy SystemThe 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. | Device | Symphony Thrombectomy system |
Primary outcome
Rate of Major Adverse Events
Time frame: 48 hours
A composite of all-cause major bleeding, device-related mortality, device-related serious adverse events
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
2 secondary outcomes
Secondary Safety Endpoints: 48 Hours
Time frame: 48 Hours
Secondary Safety Endpoints: 30 Days
Time frame: 30 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42312382Bangalore 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. Is There a Golden Hour for Thrombectomy in Intermediate-Risk Pulmonary Embolism? Insights From SYMPHONY-PE. Circ Cardiovasc Interv. 2026 Jun 18:e016573. doi: 10.1161/CIRCINTERVENTIONS.126.016573. Online ahead of print.
- Derived from this study: PubMed 40961960Bangalore 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symphony Thrombectomy System in people with Acute Pulmonary Embolism and Thromboembolism, run by Imperative Care, Inc. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Major Adverse Events (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06062329, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.