Trials Sponsors Conditions Drugs Pricing

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

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 Outcomes (3)

Assessment of the safety of Magneto PE Kit
30 (±3) days
Assessment of ease of use during the procedure
Procedure
Assessment of the impact on RV dysfunction (RV/LV ratio)
48 (±8) hours

Study Arms (1)

Magneto PE Kit

EXPERIMENTAL

Treatment with Magneto PE Kit

Device: Magneto PE Kit

Interventions

Magneto PE KitDevice

All enrolled patients will be treated with Magneto PE Kit

Magneto PE Kit

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Clinical signs, symptoms and presentation consistent with acute PE
PE symptom duration ≤ 14 days

Sponsors & Collaborators

Magneto Thrombectomy Solutions
Industrylead

Study Sites (5)

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

Related 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.
PMID: 36922052BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Enrollment

15 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 3, 2021

First Posted

July 2, 2021

Study Start

August 26, 2021

Actual (reported)

Evaluation of the Safety and Performance of Magneto PE Kit

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Magneto PE Kit

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Magneto PE Kit

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations