Evaluation of the Safety and Performance of Magneto PE Kit

Study Overview
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Brief Summary
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This study is designed as a prospective, multi-center, multinational open labeled, single armed study to evaluate the safety and performance of the Magneto PE Kit.

Official Title
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Evaluation of the Safety and Performance of Magneto PE Kit for Endovascular Thrombectomy in Patients With Acute Pulmonary Embolism

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Device: Magneto PE Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical signs, symptoms and presentation consistent with acute PE PE symptom duration ≤ 14 days CTA evidence of PE RV/LV ratio ≥ 0.9 Heart rate <130 BPM prior to procedure Subject medically eligible for interventional procedure Age ≥ 18 and <75 years Consent process is completed Exclusion Criteria: Thrombolytic use within 14 days Known bleeding diathesis or coagulation disorder Any contraindication to systemic therapeutic doses of heparin or other anticoagulants Hemodynamic collapse at presentation Decompensated heart failure Presence of Extra-Corporeal Membrane Oxygenation. Major trauma ISS> 15 within 14 days Cardiovascular or pulmonary surgery within last 7 days FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90% Hematocrit < 28% Platelets < 100,000/µL Serum creatinine > 1.8 mg/dL INR>2 Left bundle branch block PAP > 70 mmHg m Imaging evidence suggests subject is not appropriate for mechanical thrombectomy Presence of intracardiac lead in right ventricle or atrium. Pacemaker or Implantable Cardioverter Defibrillator Presence of intracardiac thrombus Anaphylactic reaction to radiographic contrast agents that cannot be pre-treated Known right- to-left shunt, Known left ventricular ejection fraction ≤ 30% History of severe chronic pulmonary arterial hypertension History of underlying lung disease with oxygen dependence History of chest irradiation History of Heparin Induced Thrombocytopenia (HIT) Female who is pregnant or nursing Current participation in another investigational drug or device treatment study Life expectancy of < 90 days as determined by the investigator Subjects who are intubated

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magneto PE Kit<br>Treatment with Magneto PE Kit | Device: Magneto PE Kit<br>* All enrolled patients will be treated with Magneto PE Kit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the safety of Magneto PE Kit | Number of patients with a composite of major adverse events within 48 (± 8) hours of the index procedure | 48 (±8) hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the safety of Magneto PE Kit | Number of patients with a composite of major adverse events within 30 (± 3) days of the index procedure | 30 (±3) days | 
| Assessment of ease of use during the procedure | Ease of use of Magneto PE Kit as assessed by a subjective questionnaire to be completed by the primary operator after the procedure | Procedure | 
| Assessment of the impact on RV dysfunction (RV/LV ratio) | RV/LV ratio assessment at 48 (±8) hours | 48 (±8) hours |