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Clinical trial Recruiting at 2 sites Observational Ages 18 to 100

Pre-emptive LAVA-ECMO support for complex, high-risk TAVR

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

Run by Atlantic Health System · NCT07309029 · Data updated 2026-11-12

The team will try pre-emptive left atrial veno-arterial ECMO to stabilize adults with severe aortic stenosis undergoing complex, high-risk TAVR who are unstable or at risk of instability.

Quick facts

Study typeObservational
Ages18 Years to 100 Years
SexAll
Enrollment30 (estimated)
SponsorAtlantic Health System
Academic / other
Locations2 sites (Detroit, Michigan and 1 other locations)
StatusRecruiting
StartedJanuary 1, 2026
Main results expectedMay 30, 2027
Study endsJune 30, 2027
Registry record updatedDecember 30, 2025
Trial IDNCT07309029 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with severe aortic stenosis scheduled for complex or high-risk TAVR who meet Class III hemodynamic criteria or have Type B/C anatomic complexity with Class II hemodynamics.

Probably not a fit

Patients having routine, low-risk TAVR who are hemodynamically stable or those with contraindications to ECMO are unlikely to benefit from pre-emptive LAVA-ECMO.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, prospective, multi-center study enrolling adults undergoing complex or high-risk transcatheter aortic valve replacement who meet predefined hemodynamic or anatomic risk criteria. Participants receive pre-emptive LAVA-ECMO cannulation prior to or during the TAVR procedure and are followed through their in-hospital course. The primary composite outcome includes in-hospital death, intraprocedural cardiac arrest, or need for emergent cardiac surgery, with secondary safety endpoints capturing major vascular, bleeding, and cardiac structural complications. Eligible patients are screened based on Class III hemodynamic instability or Type B/C anatomic complexity with Class II hemodynamic risk.

Why it matters

Potential benefit: If successful, pre-emptive LAVA-ECMO could reduce in-hospital deaths, intraprocedural cardiac arrests, and emergency surgeries by providing immediate circulatory support during high-risk TAVR.

How similar studies have gone: Small case series and observational reports have described ECMO use during TAVR, but pre-emptive LAVA-ECMO in this specific high-risk population is relatively novel and lacks robust prospective evidence.

Who can join: the full rules

Show full inclusion / exclusion 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
    * 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 Criteria:

* 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

Where it's running

  • Center for Structural Heart Disease Henry Ford Hospital
    Detroit, Michigan, United States     Recruiting
  • Valve and Structural Heart Center Morristown Medical Center
    Morristown, New Jersey, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.