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
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Need for vasopressors or inotropes to maintain MAP\>60 mmHg
* Evidence of end-organ damage including: acute kidney injury, liver dysfunction, elevated lactate or altered mentation
* Minor Criteria (Class II)
* Left ventricular ejection fraction \<35%
* Pulmonary hypertension (pulmonary artery systolic pressure \>60 mmHg) with right ventricular dysfunction
* Pulmonary capillary wedge pressure \>30 mmHg
* Anatomic criteria
* Major Criteria (Type C)
* Native or valve-in-valve TAVR requiring single-leaflet modification for a large area of myocardium at risk (e.g. patients with large or dominant left circulation)
* Native or valve-in-valve TAVR requiring dual-leaflet modification
* Severe bioprosthetic aortic regurgitation
* Severe 3-vessel coronary artery disease not amenable to revascularization (SYNTAX score \>33)
* Minor Criteria (Type B)
* Native or valve-in-valve TAVR requiring single-leaflet modification
* Severe commissural misalignment requiring leaflet modification
* High-risk for coronary occlusion not amenable to leaflet modification
* Critical low-flow low-gradient aortic stenosis (defined as an estimated aortic va…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Efficacy Endpoint: Composite of in-hospital death, intraprocedural resuscitated cardiac arrest or emergent cardiac surgery.
Timeframe: From enrollment through hospital discharge (up to 30 days post-procedure)