Status:
TERMINATED
Impella CP With VA ECMO for Cardiogenic Shock
Lead Sponsor:
University of Pennsylvania
Conditions:
Cardiogenic Shock
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) is indicated as a haemodynamic rescue strategy in decompensated acute or chronic heart failure presenting as cardiogenic shock. It has been...
Eligibility Criteria
Inclusion
- Cardiogenic shock: Including refractory to conventional therapy, including systolic blood pressure \< 90mm Hg, Cardiac Index \< 1.8 or a cardiac index \< 2.0 on moderate to high doses of inotropes and vasopressors for greater than 30 mins, or systemic signs of tissue hypoxia.
- Post-acute myocardial infarction cardiogenic shock: excluding mechanical complications requiring surgical intervention after extracorpeal membrane oxygenator (ECMO) such as post-ischaemic ventricular septal defect (VSD).
- Drug overdose-induced cardiogenic shock.
- Early graft failure: post orthotropic heart transplantation cardiogenic shock, excluding immediate intra-operative failure.
- Acute on chronic cardiomyopathy with progressive shock and decompensation unresponsive to medical therapies.
Exclusion
- Recent Significant Pulmonary Embolus
- Moderate to severe aortic valve insufficiency (AI)
- Ongoing significant sepsis
- Severe pulmonary hypertension \& shock
- Hypothermia
- Post-cardiotomy cardiogenic shock
- Continuous cardiopulmonary resuscitation (CPR) \>20-30 minutes, except if neurological status is satisfactory
- Transfer from outside hospital on VA ECMO or with history of CPR
- Listed for cardiopulmonary transplantation or being evaluated for cardiopulmonary transplantation or permanent mechanical circulatory support
- Known or suspected chronic heart failure with echocardiogram documenting left ventricular diastolic diameter \>6.5cm
- Known or suspected chronic heart failure with echocardiogram documenting left ventricular ejection fraction \< 25%
- Mechanical aortic valve replacement
- Presence of left ventricular thrombus
- Pre-existing Impella 2.5, CP, 3.5 or 5.0
- Cardiogenic shock due to primary respiratory failure
- Mechanical complications requiring surgical intervention after ECMO such as post-ischaemic VSD.
- Severe liver failure
- Active malignancy
- Acute aortic dissection
- Intracranial hemorrhage
- Neurological injury including recent cerebrovascular accident or suspected severe neurologic injury
Key Trial Info
Start Date :
March 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03431467
Start Date
March 19 2018
End Date
September 1 2023
Last Update
November 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104