Evaluation of the Safety and Performance of Magneto PE Kit

Not Applicable

Completed

• Conditions: Pulmonary Embolism

• Registration Number: NCT04949048
• Lead Sponsor: Magneto Thrombectomy Solutions

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-03
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-07-02
• Study Start: 2021-08-26
• Primary Completion: 2023-11-22
• Study Completion: 2023-12-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Aarhus Univeristy Hospital; 🇩🇰 Aarhus, Denmark

Hadassah Ein Karem Hospital; 🇮🇱 Jerusalem, Israel

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

John Paul II Hospital; 🇵🇱 Kraków, Poland

Poznan University Hospital; 🇵🇱 Poznań, Poland