NCT07019662

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: IHF GmbH - Institut für Herzinfarktforschung · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• VA-ECMO

Interventions

Type	Name	Description
DEVICE	Decannulation with a medical device	Wound Closure with a medical device
PROCEDURE	Decannulation using surgical removal or manual compression	Wound closure using surgical removal or manual compression

Timeline

• Start date: 2025-10-27
• Primary completion: 2027-02-01
• Completion: 2027-09-01
• First posted: 2025-06-13
• Last updated: 2026-04-16

Locations

2 sites across 1 country: Germany