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

RecruitingNAAges 18 Years - anyAllIHF GmbH - Institut für Herzinfarktforschung
NCT07019662 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 standa

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 Years * Femoral placement of VA-ECMO with peripheral, percutaneous cannulation * Arterial puncture site above the femoral bifurcation * Cannula size must match or be smaller than the maximally licensed diameter for Perclose™ ProStyle™ (26 F (French) outer diameter arterial and 29 F outer diameter veinous) * Patients must be eligible for either the Perclose™ ProStyle™ device or one of the two guideline-compliant alternatives for ECMO cannula removal (manual compression or surgical closure) according to the investigator's judgment. * Initial arterial and/or venous puncture for ECMO cannulation was performed using ultrasound guidance with corresponding documentation available in the patient record. Exclusion Criteria: * Severe calcification * Surgical cannulation * Ongoing Infection of the ECMO site * Any patient who does not fullfil the eligibility criteria for the use of the study device according to its current Instructions for Use (IFU), including known contraindications, limitations or warnings. * Participation in another interventional clinical trial. * Patients who are pregnant (assessed by clinical routine testing) or lactating.
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What it tests

  • Decannulation with a medical device
  • Decannulation using surgical removal or manual compression
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Where

2 sites
Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology
Frankfurt, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Zentrum für Kardiologie
Mainz, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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