Actively Recruiting
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
Eligibility Criteria
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
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
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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
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
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