Clinical trial NCT04949048: Evaluation of the Safety and Performance of Magneto PE Kit
Official title: Evaluation of the Safety and Performance of Magneto PE Kit for Endovascular Thrombectomy in Patients With Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Lead sponsor: Magneto Thrombectomy Solutions
Sponsor class: INDUSTRY
First posted: 2021-07-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the safety of Magneto PE Kit
timeFrame: 48 (±8) hours
Secondary outcomes:
measure: Assessment of the safety of Magneto PE Kit
timeFrame: 30 (±3) days
measure: Assessment of ease of use during the procedure
timeFrame: Procedure
measure: Assessment of the impact on RV dysfunction (RV/LV ratio)
timeFrame: 48 (±8) hours
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Univeristy Hospital
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Hospital
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Kraków
country: Poland
facility: John Paul II Hospital
city: Poznań
country: Poland
facility: Poznan University Hospital
Study officials:
References:
citation: 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.