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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magneto PE Kit | Experimental | Treatment with Magneto PE Kit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magneto PE Kit | Device | All enrolled patients will be treated with Magneto PE Kit |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Univeristy Hospital | Aarhus | Denmark | ||||
| Hadassah Ein Karem Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36922052 | Background | 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. |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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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 |
| Jerusalem |
| Israel |
| Sheba Medical Center | Ramat Gan | Israel |
| John Paul II Hospital | Krakow | Poland |
| Poznan University Hospital | Poznan | Poland |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |