Cardiogenic ShockNCT03740711
Early LA Venting During Venoaterial ECMO Support
A study testing Left atrial venting in people with Cardiogenic Shock and Extracorporeal Membrane Oxygenation Support, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The EVOLVE-ECMO(Early Left Atrial Venting Versus Conventional Treatment For Left VEntricular Decompression During Venoarterial ExtraCorporeal Membrane Oxygenation Support) study is a randomized controlled trial to evaluate the prognostic effect of early LA venting(when detect B-line on serial lung ultrasound) on… Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation Support, Refractory Pulmonary Edema
- What is being tested?
- Left atrial venting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Dec 2018to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject was > 18 years of age.
- Subjects who underwent successful VA-ECMO support
- Subjects with refractory cardiogenic shock who had pulmonary edema confirmed by chest X ray or lung sonogram.
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Who cannot join
- subject was <80 years of age
- Pregnant and/or lactate women
- Subjects who underwent VA-ECMO after recent open heart surgery
- Subjects who underwent VA-ECMO after non-cardiogenic arrest(trauma, hypothermia, submersion, drug overdose, asphyxia, intracranial hemorrhage etc)
- Severe bleeding tendency
- Terminal malignancy
- Known severe irreversible brain damage
- Subject was unable to provide written informed consent or participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Left Atrial Venting Versus Conventional Treatment For Left Ventricular Decompression During Venoarterial Extracorporeal Membrane Oxygenation Support (EVOLVE-ECMO Trial)
The EVOLVE-ECMO(Early Left Atrial Venting Versus Conventional Treatment For Left VEntricular Decompression During Venoarterial ExtraCorporeal Membrane Oxygenation Support) study is a randomized controlled trial to evaluate the prognostic effect of early LA venting(when detect B-line on serial lung ultrasound) on weaning VA-ECMO support in refractory CS who receive VA-ECMO support. The aim of EVOLVE-ECMO trial is to test the hypothesis that early LA venting would result in a significant reduction in failure of weaning ECMO support in refractory CS.
- Conditions
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation Support, Refractory Pulmonary Edema
- Being tested
- Left atrial venting
- Keywords
- Cardiogenic shock, Extracorporeal Membrane Oxygenation Support, Left atrial venting
- Medical subject headings
- Shock, Cardiogenic, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left atrial ventingProcedure or surgery
The contralateral femoral vein is assessed with an 7-French(Fr) sheath() and femoral artery is assessed with 5-Fr sheath( ) for fluoroscopic guidance using 5-Fr pig-tail catheter. In some cases trans-esophageal echo is used. The inter-atrial septum in punctured with a standard BRK™tran-septal needle(St. Jude Medical Inc., St. Paul, MN) under direct visualization via an 8-Fr Mullin sheath(St. Jude Medical Inc.). A SAFARI™(Boston Scientific, Galway, Ireland) guidewire is advanced into the LA. An 8-Fr Mullin-sheath is removed and atrial septostomy is performed using 21-Fr dilator. A 17-Fr or 21-Fr Biomedicus Percutaneous Femoral cannula(Medtronic Inc., Minneapolis, MN) is then placed in the LA and was attached to the ECMO circuit using a Y connector.
| Study group | Role | What they receive |
|---|---|---|
| Early LA venting | Experimental | When detect B-line on serial lung ultrasound, we will perform early LA venting for improving LV distention in patients with refractory cardiogenic shock who received VA-ECMO support. Receives: Procedure: Left atrial venting |
| Conventional LA venting | Active comparator | When detect refractory pulmonary congestion on chest radiograph or inadequate AV opening on serial echocardiography, we will perform LA venting for improving LV distention in patients with refractory cardiogenic shock who received VA-ECMO support. Receives: Procedure: Left atrial venting |
What is being measured
The primary outcome is the main question the study is designed to answer.
weaning rate of VA-ECMO
Weaning of VA-ECMO support
Measured: during index admission
Secondary outcomes (5)
In hospital mortality
Measured: during index admission
Adverse outcome due to LA venting
Measured: during index admission
Free days for mechanical ventilation
Measured: during index admission
Success rate to heart transplantation
Measured: during index admission
rate of improving for pulmonary edema
Measured: during index admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start12 Dec 2018
- Primary completion24 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies 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
- Model description
- Randomized controlled test
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min-Seok Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740711
- Sponsor's protocol ID
- AMC_2018_0646
- Status last verified
- Aug 2022
- First submitted
- 19 Oct 2018
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Left Atrial Venting Versus Conventional Treatment For Left Ventricular Decompression During Venoarterial Extracorporeal Membrane Oxygenation Support (EVOLVE-ECMO Trial)
- ClinicalTrials.gov ID
- NCT03740711
- Acronym / sponsor ID
- AMC_2018_0646
- Conditions
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation Support, Refractory Pulmonary Edema
- Keywords
- Cardiogenic shock, Extracorporeal Membrane Oxygenation Support, Left atrial venting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 14 Nov 2018 (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.
The EVOLVE-ECMO(Early Left Atrial Venting Versus Conventional Treatment For Left VEntricular Decompression During Venoarterial ExtraCorporeal Membrane Oxygenation Support) study is a randomized controlled trial to evaluate the prognostic effect of early LA venting(when detect B-line on serial lung ultrasound) on weaning VA-ECMO support in refractory CS who receive VA-ECMO support. The aim of EVOLVE-ECMO trial is to test the hypothesis that early LA venting would result in a significant reduction in failure of weaning ECMO support in refractory CS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled test
| Arm | Type | Receives |
|---|---|---|
| Early LA venting | Experimental | Procedure: Left atrial ventingWhen detect B-line on serial lung ultrasound, we will perform early LA venting for improving LV distention in patients with refractory cardiogenic shock who received VA-ECMO support. |
| Conventional LA venting | Active comparator | Procedure: Left atrial ventingWhen detect refractory pulmonary congestion on chest radiograph or inadequate AV opening on serial echocardiography, we will perform LA venting for improving LV distention in patients with refractory cardiogenic shock who received VA-ECMO support. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject was > 18 years of age.
- Subjects who underwent successful VA-ECMO support
- Subjects with refractory cardiogenic shock who had pulmonary edema confirmed by chest X ray or lung sonogram.
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Key exclusion criteria (8 listed)
- subject was <80 years of age
- Pregnant and/or lactate women
- Subjects who underwent VA-ECMO after recent open heart surgery
- Subjects who underwent VA-ECMO after non-cardiogenic arrest(trauma, hypothermia, submersion, drug overdose, asphyxia, intracranial hemorrhage etc)
- Severe bleeding tendency
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 |
|---|---|---|
| Left atrial ventingThe contralateral femoral vein is assessed with an 7-French(Fr) sheath() and femoral artery is assessed with 5-Fr sheath( ) for fluoroscopic guidance using 5-Fr pig-tail catheter. In some cases trans-esophageal echo is used. The inter-atrial septum in punctured with a standard BRK™tran-septal needle(St. Jude Medical Inc., St. Paul, MN) under direct visualization via an 8-Fr Mullin sheath(St. Jude Medical Inc.). A SAFARI™(Boston Scientific, Galway, Ireland) guidewire is advanced into the LA. An 8-Fr Mullin-sheath is removed and atrial septostomy is performed using 21-Fr dilator. A 17-Fr or 21-Fr Biomedicus Percutaneous Femoral cannula(Medtronic Inc., Minneapolis, MN) is then placed in the LA and was attached to the ECMO circuit using a Y connector. | Procedure or surgery | Conventional LA venting, Early LA venting |
Primary outcome
weaning rate of VA-ECMO
Time frame: during index admission
Weaning of VA-ECMO support
5 secondary outcomes
In hospital mortality
Time frame: during index admission
Adverse outcome due to LA venting
Time frame: during index admission
Free days for mechanical ventilation
Time frame: during index admission
Success rate to heart transplantation
Time frame: during index admission
rate of improving for pulmonary edema
Time frame: during index admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left atrial venting in people with Cardiogenic Shock and Extracorporeal Membrane Oxygenation Support, run by Asan Medical Center at 1 site in South Korea.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weaning rate of VA-ECMO (time frame: during index admission). 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 31 Aug 2022.