CompletedNot Applicable

SYMPHONY-PE Study for Treatment of Pulmonary Embolism

United States109 participantsStarted 2023-12-13

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Rate of major adverse events

Timeframe: 48 hours

Mean reduction of RV/LV ratio

Timeframe: Baseline to 48 hours

NCT IDNCT06062329

SponsorImperative Care, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-04