Early LA Venting During Venoaterial ECMO Support

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.

Study Overview

• Status: Completed
• Conditions: Cardiogenic Shock; Extracorporeal Membrane Oxygenation Support; Refractory Pulmonary Edema
• Intervention / Treatment: Procedure: Left atrial venting

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early LA venting; 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.	Procedure: Left atrial venting; 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.
Active Comparator: Conventional LA venting; 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.	Procedure: Left atrial venting; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weaning rate of VA-ECMO	Weaning of VA-ECMO support	during index admission

Secondary Outcome Measures

Outcome Measure	Time Frame
In hospital mortality	during index admission
Adverse outcome due to LA venting	during index admission
Free days for mechanical ventilation	during index admission
Success rate to heart transplantation	during index admission
rate of improving for pulmonary edema	during index admission

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Actual): August 24, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: November 11, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Cardiogenic shock; Extracorporeal Membrane Oxygenation Support; Left atrial venting
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Shock; Myocardial Infarction; Infarction; Shock, Cardiogenic; Pulmonary Edema
• Other Study ID Numbers: AMC_2018_0646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No