Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07019662

Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach

Led by IHF GmbH - Institut für Herzinfarktforschung · Updated on 2026-04-16

102

Participants Needed

2

Research Sites

96 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: Patients with severe heart and lung failure may be treated with VA-ECMO (veno-arterial extracorporeal membrane oxygenation), a life-support machine that temporarily takes over the function of the heart and lungs. To connect the patient to ECMO, large tubes (cannulas) are inserted into major blood vessels in the groin area. When the patient no longer needs ECMO, these cannulas must be removed - a process known as decannulation. Closing the artery after removing the cannula is a critical step and can be associated with complications such as bleeding, vessel injury, or blood clots. Currently, there are different methods to close the artery: * Surgical closure: open surgery to directly suture the artery * Manual compression: pressing on the artery to stop bleeding * Vascular closure devices (VCDs): special tools that close the artery through the skin There is no clear standard yet on which method is safest and most effective for ECMO patients. Purpose of the Study: The study aims to determine whether using a vascular closure device is as safe and effective as the current standard methods for femoral artery closure after VA-ECMO. Study Design: This is a randomized controlled trial. Patients who are scheduled for decannulation after VA-ECMO support will be randomly assigned to one of two groups: * Intervention Group: Patients receive a vascular closure device to seal the artery (Abbott Perclose™ ProStyle™ Suture-Mediated Closure System). * Control Group: Patients receive standard care, which may be either: * Manual compression, or * Surgical closure, depending on the treating physician's judgment and the patient's condition. This allows for a real-world comparison of the Closure Device method to current clinical practice.

CONDITIONS

Official Title

Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 2 18 Years
  • Femoral placement of VA-ECMO with peripheral, percutaneous cannulation
  • Arterial puncture site above the femoral bifurcation
  • Cannula size matching or smaller than the licensed diameter for Perclose2 ProStyle2 (26 F outer diameter arterial and 29 F outer diameter venous)
  • Eligibility for Perclose2 ProStyle2 device or guideline-compliant manual compression or surgical closure based on investigator judgment
  • Initial arterial and/or venous puncture performed with ultrasound guidance and documented in patient records
Not Eligible

You will not qualify if you...

  • Severe calcification
  • Surgical cannulation
  • Ongoing infection at the ECMO site
  • Does not meet eligibility for use of the study device per its Instructions for Use, including contraindications, limitations, or warnings
  • Participation in another interventional clinical trial
  • Pregnant or lactating patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology

Frankfurt, Germany

Actively Recruiting

2

Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Zentrum für Kardiologie

Mainz, Germany

Actively Recruiting

Loading map...

Research Team

J

Jelena Weller

CONTACT

M

Marcel Kunadt, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here