RecruitingNCT07309029

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

PROspective Evaluation of Pre-empTive Left Atrial Venoarterial Extra-Corporeal Membrane oxygenaTion for Complex High-risk Transcatheter Aortic Valve Replacement: PROTECT-TAVR

Sponsor

Atlantic Health System

Enrollment

30 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

Severe aortic stenosis Cardiogenic Shock Trans-catheter Aortic Valve Implantation Cardiogenic Shock, ECMO

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria21

\- 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 valve area ≤0.5 cm2)

Exclusion Criteria11

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

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Interventions

DEVICELeft Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO)

Pre-emptive use of LAVA-ECMO involves transseptal cannulation of the left atrium to provide mechanical circulatory support and left ventricular unloading during high-risk transcatheter aortic valve replacement (TAVR). The device is placed prior to or at the start of the TAVR procedure in patients with unstable hemodynamics or complex anatomical features.