Clinical trial NCT06062329: SYMPHONY-PE Study for Treatment of Pulmonary Embolism
Official title: Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Pulmonary Embolism
Thromboembolism
Emboli, Pulmonary
Thrombosis
Thrombus; Embolism
Embolism
Cardiovascular Diseases
Vascular Diseases
Keywords: Thrombectomy
Submassive Pulmonary Embolism
Right Ventricle dysfunction
Lead sponsor: Imperative Care, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-02
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Rate of major adverse events
timeFrame: 48 hours
measure: Mean reduction of RV/LV ratio
timeFrame: Baseline to 48 hours
Secondary outcomes:
measure: Rates of Major bleeding, device-related mortality, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury
timeFrame: 48 Hours
measure: Rates of PE related mortality, all-cause mortality, device-related SAEs and symptomatic PE recurrence
timeFrame: 30 Days
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Huntsville Hospital
state: Alabama
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Glenview
country: United States
facility: Endeavor Health
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Detroit
country: United States
facility: Ascension St John Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital - Royal Oak
state: Michigan
city: Mount Kisco
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: NYU Grossman School of Medicine
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cincinnati
country: United States
facility: Bon Secours Mercy Health, Inc
state: Ohio
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Fort Worth
country: United States
facility: Medical City Fort Worth Hospital
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
Study officials:
References: