NCT07309029 · Atlantic Health System
Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR
(PROTECT-TAVR)
What this study is about
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).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Detroit, Michigan
- Morristown, New Jersey
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 30, 2025 · Source of record for eligibility and locations