Evaluation of the Safety and Performance of Magneto PE Kit

NCT04949048 | Completed

• 1 other identifier: KT1-CLN001
• Study Type: interventional
• Target: 15
• Locations: 3 countries
• Sites: 5

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

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 Kit DEVICE

All enrolled patients will be treated with Magneto PE Kit

Magneto PE Kit

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Magneto Thrombectomy Solutions: lead

Study Sites (5)

Aarhus Univeristy Hospital

Aarhus, Denmark

Location

Hadassah Ein Karem Hospital

Jerusalem, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

John Paul II Hospital

Krakow, Poland

Location

Poznan University Hospital

Poznan, Poland

Location

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: 36922052 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

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
• Primary Completion: November 22, 2023
• Study Completion: December 21, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); PL (2); IL (2)