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Completed

NCT Number: NCT03740711

Early LA Venting During Venoaterial ECMO Support

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.

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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases Extracorporeal Membrane Oxygenation Support Heart Diseases Infarction Ischemia Lung Diseases Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Edema Refractory Pulmonary Edema Respiratory Tract Diseases Shock Shock, Cardiogenic Vascular Diseases

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Left atrial venting

Procedure

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.

Primary outcomes

  1. weaning rate of VA-ECMO

    Time frame: during index admission

    Weaning of VA-ECMO support

Secondary outcomes

  1. In hospital mortality

    Time frame: during index admission

  2. Adverse outcome due to LA venting

    Time frame: during index admission

  3. Free days for mechanical ventilation

    Time frame: during index admission

  4. Success rate to heart transplantation

    Time frame: during index admission

  5. rate of improving for pulmonary edema

    Time frame: during index admission

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 14, 2018
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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