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

NCT07019662 | Recruiting

• 1 other identifier: MDR-004
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of a combined vessel-orientated clinical endpoint (VOCE)

  within 48 hours post ECMO removal

Secondary Outcomes (10)

• Length of ICU (intensive care unit) stay post ECMO removal

  Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first

• Length of hospital stay post ECMO removal

  Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first

• Time to mobilization post ECMO removal

  Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first

• Costs of hospital stay

  Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first

• Incidence of Bleeding requiring transfusion (BARC3a)

  At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first

Study Arms (2)

Decannulation using the Perclose™ ProStyle™

EXPERIMENTAL

Device: Decannulation with a medical device

Standard of Care: Decannulation using surgical removal or manual compression

ACTIVE COMPARATOR

Procedure: Decannulation using surgical removal or manual compression

Interventions

Decannulation with a medical device DEVICE

Wound Closure with a medical device

Decannulation using the Perclose™ ProStyle™

Decannulation using surgical removal or manual compression PROCEDURE

Wound closure using surgical removal or manual compression

Standard of Care: Decannulation using surgical removal or manual compression

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IHF GmbH - Institut für Herzinfarktforschung: lead

Study Sites (2)

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

Frankfurt, Germany

RECRUITING

Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Zentrum für Kardiologie

Mainz, Germany

RECRUITING

Study Officials

• Robert Stöhr, PD Dr. Dr.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jelena Weller

CONTACT

+49 62159577216; close-ecmo@ihf.de

Marcel Kunadt, Dr.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 13, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

DE (2)