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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
All enrolled patients will be treated with Magneto PE Kit
Aarhus Univeristy Hospital
Aarhus, Denmark
Hadassah Ein Karem Hospital
Jerusalem, Israel
Sheba Medical Center
Ramat Gan, Israel
John Paul II Hospital
Krakow, Poland
Poznan University Hospital
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
Time frame: 48 (±8) hours
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
Time frame: 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
Time frame: Procedure
Assessment of the impact on RV dysfunction (RV/LV ratio)
RV/LV ratio assessment at 48 (±8) hours
Time frame: 48 (±8) hours
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Poznan, Poland