SYMPHONY-PE Study for Treatment of Pulmonary Embolism

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062329
• Other study ID #: TRU-2023-001
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2023
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: Imperative Care, Inc.
• Contact: Sylvie Akiel-Fu, MPH
• Phone: 917-375-4735
• Email: safu[@]imperativecare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acute Pulmonary Embolism
• Cardiovascular Diseases
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Thrombus; Embolism
• Vascular Diseases

Intervention

Device:
• Symphony Thrombectomy System
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.

Locations

Country	Name	City	State
United States	Corewell Health	Grand Rapids	Michigan
United States	Huntsville Hospital	Huntsville	Alabama
United States	Northwell Health	Mount Kisco	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	William Beaumont Hospital - Royal Oak	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Imperative Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of major adverse events	Major bleeding, device-related mortality, device-related serious adverse events	48 hours
Primary	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	Rates of Major bleeding, device-related mortality, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury	Evaluate rates of major bleeding, device-related mortality, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury	48 Hours
Secondary	Rates of PE related mortality, all-cause mortality, device-related SAEs and symptomatic PE recurrence	Evaluate rates of PE related mortality, All-cause mortality, Device-related SAEs and Symptomatic PE recurrence	30 Days