Pulmonary Embolism Clinical Trial
Official title:
Evaluation of the Safety and Performance of Magneto PE Kit for Endovascular Thrombectomy in Patients With Acute Pulmonary Embolism
Verified date | March 2024 |
Source | Magneto Thrombectomy Solutions |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | December 21, 2023 |
Est. primary completion date | November 22, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus Univeristy Hospital | Aarhus | |
Israel | Hadassah Ein Karem Hospital | Jerusalem | |
Israel | Sheba Medical Center | Ramat Gan | |
Poland | John Paul II Hospital | Kraków | |
Poland | Poznan University Hospital | Poznan |
Lead Sponsor | Collaborator |
---|---|
Magneto Thrombectomy Solutions |
Denmark, Israel, Poland,
Andersen A, Musialek P, Araszkiewicz A, Schultz J, Nielsen-Kudsk JE, Tekieli L, Zajdel W, Slawek-Szmyt S, Taff Y, Weinberg I. First-in-Human Trial of Mechanical-Electric Thrombectomy in Acute Pulmonary Embolism. JACC Cardiovasc Interv. 2023 Mar 13;16(5):623-625. doi: 10.1016/j.jcin.2022.12.021. Epub 2023 Feb 8. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Assessment of the impact on RV dysfunction (RV/LV ratio) | RV/LV ratio assessment at 48 (±8) hours | 48 (±8) hours |
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