Evaluation of the Safety and Performance of Magneto PE Kit

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949048
• Other study ID #: KT1-CLN001
• Status: Completed
• Phase: N/A
• Start date: August 26, 2021
• Est. completion date: December 21, 2023

Study information

• Verified date: March 2024
• Source: Magneto Thrombectomy Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• Magneto PE Kit
All enrolled patients will be treated with Magneto PE Kit

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Magneto Thrombectomy Solutions

Countries where clinical trial is conducted

Denmark,  Israel,  Poland, 

References & Publications (1)

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

Outcome

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