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LAVA-ECMO for High-Risk TAVR

This study is looking at adults with severe aortic stenosis (a narrowing of the heart's main valve) who need a Trans-catheter Aortic Valve Replacement (TAVR) but are at high risk due to their heart condition. Researchers want to see if using Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO) before TAVR can reduce serious problems like in-hospital death, cardiac arrest during the procedure, or the need for emergency heart surgery. LAVA-ECMO is a device that helps support your heart and lungs. The study also aims to understand the safety of LAVA-ECMO, including risks like bleeding. You might be able to join if you are between 18 and 100 years old, have severe aortic stenosis, and meet specific criteria for being hemodynamically (blood flow) unstable or at risk. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information about 30 participants receiving LAVA-ECMO during high-risk TAVR.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants from enrollment through hospital discharge, up to 30 days after the procedure, to track outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07309029

Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR

Recruiting
Not specifiedAges 18+Observational
Atlantic Health System
~30 participants
Updated 2025-12-30 on ClinicalTrials.gov
What's tested:Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Efficacy Endpoint: Composite of in-hospital death, intraprocedural resuscitated cardiac arrest or emergent cardiac surgery.
Measured over From enrollment through hospital discharge (up to 30 days post-procedure)

Conditions

Severe Aortic Stenosis
Cardiogenic Shock
Cardiogenic Shock, ECMO
Trans-catheter Aortic Valve Implantation

Explore related trials

Aortic Valve Stenosis

Where it's being run

2 sites across 2 states
Michigan1
New Jersey1

Who to contact

Gennaro Giustino, MD
[email protected]
9739718858
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 valve area ≤0.5 cm2)

Exclusion

Age \<18 or pregnant
General absolute contraindications to TAVR
Severe peripheral artery disease with infeasibility for veno-arterial extracorporeal membrane oxygenation implantation.
Contraindications to transeptal cannulation (e.g. pre-existing interatrial septum occluder device).
Pre-existing Impella treatment.
Onset of shock \>12 hours.
Preceding cardiac arrest with prolonged resuscitation (\>40 minutes).
Other severe concomitant disease with life expectancy \<6 months.
Participation in another trial with an intervention.
Any class I hemodynamic status
Type A anatomical complexity with class I or II hemodynamic status

What this trial measures

  • Primary Efficacy Endpoint: Composite of in-hospital death, intraprocedural resuscitated cardiac arrest or emergent cardiac surgery.From enrollment through hospital discharge (up to 30 days post-procedure)