Evaluation of the Safety and Performance of Magneto PE Kit

NCT ID: NCT04949048

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-26
• Study Completion Date: 2023-12-21

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.

Conditions

Pulmonary Embolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Magneto PE Kit

Treatment with Magneto PE Kit

Group Type: EXPERIMENTAL

Magneto PE Kit

Intervention Type: DEVICE

All enrolled patients will be treated with Magneto PE Kit

Interventions

Magneto PE Kit

All enrolled patients will be treated with Magneto PE Kit

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Magneto Thrombectomy Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Poznan, , Poland

Countries

Denmark; Israel; Poland

References

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.

Reference Type: BACKGROUND

PMID: 36922052 (View on PubMed)

Other Identifiers

KT1-CLN001

Identifier Type: -

Identifier Source: org_study_id