A Prospective Randomised Trial of Early LV Venting Using Impella CP for Recovery in patients with cardiogenic managed with VA ECMO (REVERSE)
Recruiting
99 years or below
All
96 participants needed
1 Location
Brief description of study
Veno-arterial (VA) extra-corporeal membrane oxygenation (ECMO) is indicated as a haemodynamic rescue
strategy in decompensated acute or chronic heart failure presenting as cardiogenic shock. VA ECMO
has a number of effects on the circulation including (i) perfusing end-organs, (ii) ventricular unloading,
and (iii) improved coronary perfusion. It is a bridge to further therapies, to withdrawal of advanced therapies or to cardiac recovery. The VA ECMO platform in combination with a left ventricle (LV) vent allows for optimization of mechanical load of the LV, and thus for LV recovery. Over the last two decades, a large body of evidence has amassed to provide compelling evidence that mechanical load optimisation is critical to recovering the LV.
The Impella device provides a percutaneous means of direct ventricular unloading with a remarkable safety profile. There is non-randomised data that suggests the addition of Impella CP in combination with VA ECMO improves survival and cardiac recovery in patients with cardiogenic shock.
This research study will provide valuable data on changes at multiple levels with full and iteratively
reduced mechanical circulatory support. It will provide the first randomised data to address this question directly.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cardiogenic Shock
-
Age: 99 years or below
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Gender: All
Updated on
19 Feb 2024.
Study ID: 828198