Evaluation of the Safety and Performance of Magneto PE Kit

Evaluation of the Safety and Performance of Magneto PE Kit for Endovascular Thrombectomy in Patients With Acute Pulmonary Embolism

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 Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: Magneto PE Kit

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus Univeristy Hospital
• Israel
  • Jerusalem, Israel
    • Hadassah Ein Karem Hospital
  • Ramat Gan, Israel
    • Sheba Medical Center
• Poland
  • Kraków, Poland
    • John Paul II Hospital
  • Poznań, Poland
    • Poznan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magneto PE Kit; Treatment with Magneto PE Kit	Device: Magneto PE Kit; All enrolled patients will be treated with Magneto PE Kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Assessment of the impact on RV dysfunction (RV/LV ratio)	RV/LV ratio assessment at 48 (±8) hours	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	30 (±3) days

Collaborators and Investigators

• Sponsor: Magneto Thrombectomy Solutions

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2021
• Primary Completion (Actual): November 22, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: January 3, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: KT1-CLN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No