Actively Recruiting
Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR
Led by Atlantic Health System · Updated on 2025-12-30
30
Participants Needed
2
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 anatomical complexity. The main questions it aims to answer are: 1. Does pre-emptive LAVA-ECMO reduce the incidence of in-hospital death, intraprocedural cardiac arrest, or emergent cardiac surgery? 2. What are the safety outcomes related to LAVA-ECMO, including major vascular, bleeding, or cardiac structural complications? -This is a single-arm, prospective, multi-center study with no comparison group. Participants will: * Be screened for eligibility based on hemodynamic status and anatomical complexity * Undergo pre-emptive LAVA-ECMO cannulation prior to or during TAVR * Receive follow-up assessments at 30 days and 1 year, including clinical evaluation and echocardiography
CONDITIONS
Official Title
Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have either Class III hemodynamic status or Type B or C anatomical complexity with Class II hemodynamics
- Class III hemodynamic criteria include systolic blood pressure <90 mmHg or mean arterial pressure <60 mmHg, need for vasopressors or inotropes to maintain MAP >60 mmHg, or evidence of end-organ damage such as acute kidney injury, liver dysfunction, elevated lactate, or altered mentation
- Class II hemodynamic criteria include left ventricular ejection fraction <35%, pulmonary hypertension with right ventricular dysfunction, or pulmonary capillary wedge pressure >30 mmHg
- Type C anatomical criteria include native or valve-in-valve TAVR requiring single- or dual-leaflet modification, severe bioprosthetic aortic regurgitation, or severe three-vessel coronary artery disease not amenable to revascularization (SYNTAX score >33)
- Type B anatomical criteria include native or valve-in-valve TAVR requiring single-leaflet modification, severe commissural misalignment requiring leaflet modification, high-risk coronary occlusion not amenable to leaflet modification, or critical low-flow low-gradient aortic stenosis (aortic valve area ≤0.5 cm2)
You will not qualify if you...
- Age under 18 years or pregnant
- Absolute contraindications to TAVR
- Severe peripheral artery disease preventing veno-arterial ECMO implantation
- Contraindications to transseptal cannulation such as pre-existing interatrial septum occluder device
- Current treatment with an Impella device
- Onset of shock more than 12 hours prior
- Prolonged cardiac arrest with resuscitation over 40 minutes
- Other severe diseases with life expectancy less than 6 months
- Participation in another trial involving an intervention
- Class I hemodynamic status
- Type A anatomical complexity with Class I or II hemodynamic status
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Center for Structural Heart Disease Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
2
Valve and Structural Heart Center Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
Research Team
G
Gennaro Giustino, MD
CONTACT
P
Pedro Villablanca, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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