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Early LA Venting During Venoaterial ECMO Support

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ClinicalTrials.gov Identifier: NCT03740711
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Min-Seok Kim, Asan Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiogenic Shock Extracorporeal Membrane Oxygenation Support Refractory Pulmonary Edema Procedure: Left atrial venting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled test
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Left Atrial Venting Versus Conventional Treatment For Left Ventricular Decompression During Venoarterial Extracorporeal Membrane Oxygenation Support
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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.




Primary Outcome Measures :
  1. weaning rate of VA-ECMO [ Time Frame: during index admission ]
    Weaning of VA-ECMO support


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740711


Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Min Seok Kim, PhD    02-3010-3948    guess124@gmail.com   
Contact: Hanbit Park, MD    02-3010-0169    phb8012@gmail.com   
Sponsors and Collaborators
Asan Medical Center

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Responsible Party: Min-Seok Kim, Clinical assistant professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03740711     History of Changes
Other Study ID Numbers: AMC_2018_0646
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Min-Seok Kim, Asan Medical Center:
Cardiogenic shock
Extracorporeal Membrane Oxygenation Support
Left atrial venting

Additional relevant MeSH terms:
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Pulmonary Edema
Shock, Cardiogenic
Lung Diseases
Respiratory Tract Diseases
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Shock
Pathologic Processes