Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR
Recruiting
Observational Study
Severe Aortic Stenosis
Cardiogenic Shock
Cardiogenic Shock, ECMO
Trans-catheter Aortic Valve Implantation
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 100
- Sex
- Any
- Study type
- Observational
- Participants needed
- 30 (estimated)
- Sponsor
- Atlantic Health System · Other
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About This Trial
The goal of this clinical trial is to evaluate the feasibility, effectiveness, and safety of pre-emptive left atrial veno-arterial extracorporeal membrane oxygenation (LAVA-ECMO) in patients undergoing complex and high-risk transcatheter aortic valve replacement (TAVR). These patients include adults with severe aortic stenosis who are hemodynamically unstable or at risk of instability due to anato…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
\- Patients are required to have either a Class III hemodynamic status OR type B or type C anatomical complexity with Class II (at risk) hemodynamics (Figure 2).
* Hemodynamic Criteria
* Major Criteria (Class III)
* Systolic blood pressure \<90 mmHg or MAP\<60 mmHg
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Contacts