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Evaluation of the Safety and Performance of Magneto PE Kit

Primary Purpose

Pulmonary Embolism

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Magneto PE Kit
Sponsored by
Magneto Thrombectomy Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus Univeristy Hospital
  • Hadassah Ein Karem HospitalRecruiting
  • Sheba Medical CenterRecruiting
  • John Paul II HospitalRecruiting
  • Poznan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magneto PE Kit

Arm Description

Treatment with Magneto PE Kit

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Assessment of the impact on RV dysfunction (RV/LV ratio)
RV/LV ratio assessment at 48 (±8) hours

Full Information

First Posted
January 3, 2021
Last Updated
April 3, 2023
Sponsor
Magneto Thrombectomy Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT04949048
Brief Title
Evaluation of the Safety and Performance of Magneto PE Kit
Official Title
Evaluation of the Safety and Performance of Magneto PE Kit for Endovascular Thrombectomy in Patients With Acute Pulmonary Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Magneto Thrombectomy Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magneto PE Kit
Arm Type
Experimental
Arm Description
Treatment with Magneto PE Kit
Intervention Type
Device
Intervention Name(s)
Magneto PE Kit
Intervention Description
All enrolled patients will be treated with Magneto PE Kit
Primary Outcome Measure Information:
Title
Assessment of the safety of Magneto PE Kit
Description
Number of patients with a composite of major adverse events within 48 (± 8) hours of the index procedure
Time Frame
48 (±8) hours
Secondary Outcome Measure Information:
Title
Assessment of the safety of Magneto PE Kit
Description
Number of patients with a composite of major adverse events within 30 (± 3) days of the index procedure
Time Frame
30 (±3) days
Title
Assessment of ease of use during the procedure
Description
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
Title
Assessment of the impact on RV dysfunction (RV/LV ratio)
Description
RV/LV ratio assessment at 48 (±8) hours
Time Frame
48 (±8) hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tami Abudi
Phone
0765300768
Email
tami@magts.com
Facility Information:
Facility Name
Aarhus Univeristy Hospital
City
Aarhus
Country
Denmark
Individual Site Status
Completed
Facility Name
Hadassah Ein Karem Hospital
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Palner, Dr.
Phone
03-5302441
Email
Planer@hadassah.org.il
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Segev, Prof.
Phone
03-5302604
Email
Amit.Segev@sheba.health.gov.il
Facility Name
John Paul II Hospital
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Musialek, Prof.
Facility Name
Poznan University Hospital
City
Poznań
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksander Araszkiewicz, Prof.
Email
aaraszkiewicz@interia.pl

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36922052
Citation
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.
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Evaluation of the Safety and Performance of Magneto PE Kit

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