Pulmonary Embolism
Conditions
Brief summary
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.
Interventions
DEVICEMagneto PE Kit
All enrolled patients will be treated with Magneto PE Kit
Sponsors
Magneto Thrombectomy Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the safety of Magneto PE Kit | 48 (±8) hours | Number of patients with a composite of major adverse events within 48 (± 8) hours of the index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the safety of Magneto PE Kit | 30 (±3) days | Number of patients with a composite of major adverse events within 30 (± 3) days of the index procedure |
| Assessment of ease of use during the procedure | Procedure | Ease of use of Magneto PE Kit as assessed by a subjective questionnaire to be completed by the primary operator after the procedure |
| Assessment of the impact on RV dysfunction (RV/LV ratio) | 48 (±8) hours | RV/LV ratio assessment at 48 (±8) hours |
Countries
Denmark, Israel, Poland
Outcome results
None listed