Heart-lung support during complex, high-risk aortic valve replacement for severe aortic stenosis
Watches how LAVA-ECMO support works and how safe it is during complex valve replacement.
Key facts
- Who runs it
- Atlantic Health System
- Where
- Detroit and Morristown, United StatesSee the 2 sites
- Trial code
- Registry title
- Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 1 Jan 2026
- Expected to end
- 30 Jun 2027
- Type of study
- Observational
- Treatments tested
- Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO)
- Record updated
- 30 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults having a complex, high-risk transcatheter aortic valve replacement (TAVR) for severe aortic stenosis. Their heart is unstable or at risk of becoming unstable.
- Age
- 18 to 100 years
- Sex
- All sexes can join.
- Disease stage
- Severe aortic stenosis with unstable blood circulation (Class III), or complex valve anatomy (type B or C) with circulation at risk (Class II).
- Earlier treatment
- People with a pre-existing Impella treatment cannot join.
Main reasons for not taking part
- Under 18 years old, or pregnant
- Severe peripheral artery disease that makes the ECMO device impossible to place
- Contraindications to transeptal cannulation, such as an interatrial septum occluder device
- Shock that began more than 12 hours ago, or cardiac arrest with resuscitation over 40 minutes
- Other severe disease with life expectancy under 6 months
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Where in United States
- Center for Structural Heart Disease Henry Ford HospitalDetroit, United StatesContact: Pedro Villablanca, MDTaking people
- Valve and Structural Heart Center Morristown Medical CenterMorristown, United StatesContact: Gennaro Giustino, MDTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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
Treatments tested
- Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- PROspective Evaluation of Pre-empTive Left Atrial Venoarterial Extra-Corporeal Membrane oxygenaTion for Complex High-risk Transcatheter Aortic Valve Replacement: PROTECT-TAVR
- Plain-language title
- Heart-lung support during complex, high-risk aortic valve replacement for severe aortic stenosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07309029, who can take part
- Record updated
- 30 December 2025