Pre-emptive LAVA-ECMO support 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
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 type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Atlantic Health System Academic / other |
| Locations | 2 sites (Detroit, Michigan and 1 other locations) |
| Trial ID | NCT07309029 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Detroit, Michigan and 1 other locations
- 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
- Study coordinator: Gennaro Giustino, MD
- Email: Gennaro.Giustino@atlantichealth.org
- Phone: 9739718858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.