Status:
TERMINATED
Early Insertion of Axillary Impella® With VA ECMO
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Cardiogenic Shock
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) is used as a rescue strategy for patients in acute hemodynamic deterioration such as cardiogenic shock and cardiopulmonary arrest with seve...
Detailed Description
This prospective, single-arm trial will include all consecutive patients undergoing cannulation of peripheral VA ECMO at the Massachusetts General Hospital (MGH) from April 2019 to March 2020. All enr...
Eligibility Criteria
Inclusion
- Age ≥18
- Impaired LV systolic function with ≤35% of left ventricular ejection fraction (LVEF)
- Enlarged LV with ≥50mm of left ventricular diastolic diameter (LVEDD) on echocardiogram
Exclusion
- Non-cardiac etiology
- Surgically correctable cardiac abnormality
- Recent significant pulmonary embolism
- Severe pulmonary hypertension
- Acute aortic dissection
- Presence of mechanical aortic valve prosthesis
- Presence of left ventricle thrombus
- Pre-existing Impella® 5.0
- Critical aortic stenosis
- Uncorrectable system malperfusion under ECMO support
- Significant cerebrovascular accident
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04084015
Start Date
October 1 2019
End Date
March 23 2021
Last Update
June 29 2021
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114