Early LA Venting During Venoaterial ECMO Support

Cardiogenic Shock Clinical Trial

Official title:

Early Left Atrial Venting Versus Conventional Treatment For Left Ventricular Decompression During Venoarterial Extracorporeal Membrane Oxygenation Support (EVOLVE-ECMO Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03740711
• Other study ID #: AMC_2018_0646
• Status: Completed
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: August 30, 2022

Study information

• Verified date: August 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 30, 2022
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiogenic Shock
• Extracorporeal Membrane Oxygenation Support
• Pulmonary Edema
• Refractory Pulmonary Edema
• Shock, Cardiogenic

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weaning rate of VA-ECMO	Weaning of VA-ECMO support	during index admission
Secondary	In hospital mortality		during index admission
Secondary	Adverse outcome due to LA venting		during index admission
Secondary	Free days for mechanical ventilation		during index admission
Secondary	Success rate to heart transplantation		during index admission
Secondary	rate of improving for pulmonary edema		during index admission