VA-ECMOCLOSE-ECMONCT07019662
Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach
A study testing Decannulation with a medical device and Decannulation using surgical removal or manual compression in people with VA-ECMO, run by IHF GmbH - Institut für Herzinfarktforschung at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VA-ECMO
- What is being tested?
- Decannulation with a medical device and Decannulation using surgical removal or manual compression
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesGermany
- Study dates
- 27 Oct 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marcel Kunadt, Dr. contact
Germany2 sites, 2 recruiting
- Recruiting
Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology
Frankfurt
- Recruiting
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Zentrum für Kardiologie
Mainz
About this study
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.
Read more
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
- Being tested
- Decannulation with a medical device, Decannulation using surgical removal or manual compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decannulation with a medical deviceDevice
Wound Closure with a medical device
Decannulation using surgical removal or manual compressionProcedure or surgery
Wound closure using surgical removal or manual compression
| Study group | Role | What they receive |
|---|---|---|
| Decannulation using the Perclose™ ProStyle™ | Experimental | Not described Receives: Device: Decannulation with a medical device |
| Standard of Care: Decannulation using surgical removal or manual compression | Active comparator | Not described Receives: Procedure: Decannulation using surgical removal or manual compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of a combined vessel-orientated clinical endpoint (VOCE)
Measured: within 48 hours post ECMO removal
Secondary outcomes (10)
Length of ICU (intensive care unit) stay post ECMO removal
Measured: Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Length of hospital stay post ECMO removal
Measured: Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Time to mobilization post ECMO removal
Measured: Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Costs of hospital stay
Measured: Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Incidence of Bleeding requiring transfusion (BARC3a)
Measured: At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Vascular complication requiring surgical or interventional therapy
Measured: At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Wound infection requiring antibiotic use or surgical debridement
Measured: At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Rate of pseudoaneurysms as detected by vascular Ultrasound
Measured: At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Rate of veinous thrombosis in the lower vessels as detected by vascular ultrasound
Measured: At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Rate of arterial thrombosis in the lower vessel as detected by vascular ultrasound
Measured: At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start27 Oct 2025
- Primary completionFeb 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VA-ECMOStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IHF GmbH - Institut für Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Stöhr, PD Dr. Dr., Principal investigator, Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019662
- Sponsor's protocol ID
- MDR-004
- Acronym
- CLOSE-ECMO
- Status last verified
- Nov 2026
- First submitted
- 26 May 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach
- ClinicalTrials.gov ID
- NCT07019662
- Acronym / sponsor ID
- CLOSE-ECMO / MDR-004
- Conditions
- VA-ECMO
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- IHF GmbH - Institut für HerzinfarktforschungUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decannulation with a medical deviceWound Closure with a medical device | Device | Decannulation using the Perclose™ ProStyle™ |
| Decannulation using surgical removal or manual compressionWound closure using surgical removal or manual compression | Procedure or surgery | Standard of Care: Decannulation using surgical removal or manual compression |
Primary outcome
Incidence of a combined vessel-orientated clinical endpoint (VOCE)
Time frame: within 48 hours post ECMO removal
10 secondary outcomes
Length of ICU (intensive care unit) stay post ECMO removal
Time frame: Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Length of hospital stay post ECMO removal
Time frame: Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Time to mobilization post ECMO removal
Time frame: Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Costs of hospital stay
Time frame: Prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Incidence of Bleeding requiring transfusion (BARC3a)
Time frame: At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Vascular complication requiring surgical or interventional therapy
Time frame: At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Wound infection requiring antibiotic use or surgical debridement
Time frame: At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Rate of pseudoaneurysms as detected by vascular Ultrasound
Time frame: At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Rate of veinous thrombosis in the lower vessels as detected by vascular ultrasound
Time frame: At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Rate of arterial thrombosis in the lower vessel as detected by vascular ultrasound
Time frame: At 48 hours post-ECMO and prior to hospital discharge, but no longer than 30 days after ECMO decannulation, whichever occurs first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
Related trials for VA-ECMO
RecruitingObservational study
Validation of Continuous Transcutaneous Carbon Dioxide Monitoring in VA-ECMO Patients
Carbon Dioxide
RecruitingPhase 1
Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO
Cardiogenic Shock, Extracorporeal Membrane Oxygenation
Enrolling by invitation
Optimizing Breathing and Blood Flow in Patients Treated With VA ECMO
VA-ECMO
RecruitingPhase 3
RECOMMEND Platform Trial
Extracorporeal Membrane Oxygenation Complication, ARDS (Acute Respiratory Distress Syndrome)
RecruitingPhase 2
Physiology of Unloading VA ECMO Trial
Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcel Kunadt, Dr. contact
Robert Stöhr, PD Dr. Dr. principal investigator
Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decannulation with a medical device and Decannulation using surgical removal or manual compression in people with VA-ECMO, run by IHF GmbH - Institut für Herzinfarktforschung at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jelena Weller (+49 62159577216, close-ecmo@ihf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of a combined vessel-orientated clinical endpoint (VOCE) (time frame: within 48 hours post ECMO removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.