Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research.
VARC-3 WRITING COMMITTEE:, Philippe Généreux, Nicolo Piazza...
https://pubmed.ncbi.nlm.nih.gov/33888385Actively Recruiting
Age: 18Years - 100Years
All Genders
ID07309029
PROspective Evaluation of Pre-empTive Left Atrial Venoarterial Extra-Corporeal Membrane oxygenaTion for Complex High-risk Transcatheter Aortic Valve Replacement: PROTECT-TAVR
Led by Atlantic Health System · Updated on 2025-12-30
30
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of pre-emptive left atrial veno-arterial extracorporeal membrane oxygenation (LAVA-ECMO) in adults undergoing complex and high-risk transcatheter aortic valve replacement (TAVR). This study focuses on patients with severe aortic stenosis who are either hemodynamically unstable or at risk of instability due to anatomical complexity. The trial aims to determine if LAVA-ECMO can reduce the risk of in-hospital death, cardiac arrest during the procedure, or emergency cardiac surgery, as well as assess safety outcomes related to major vascular, bleeding, or cardiac complications.
CONDITIONS
Brief Title
Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR
Who Can Participate
Age: 18Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients must have either Class III hemodynamic status or type B or C anatomical complexity with Class II (at risk) hemodynamics.
- Major hemodynamic criteria include systolic blood pressure below 90 mmHg or mean arterial pressure below 60 mmHg.
- Need for vasopressors or inotropes to maintain mean arterial pressure above 60 mmHg.
- Evidence of end-organ damage such as acute kidney injury, liver dysfunction, elevated lactate, or altered mentation.
- Minor hemodynamic criteria include left ventricular ejection fraction below 35%.
- Pulmonary hypertension with right ventricular dysfunction.
- Pulmonary capillary wedge pressure above 30 mmHg.
- Major anatomic criteria include native or valve-in-valve TAVR requiring single or dual-leaflet modification affecting large myocardium.
- Severe bioprosthetic aortic regurgitation.
- Severe three-vessel coronary artery disease not suitable for revascularization (SYNTAX score above 33).
- Minor anatomic criteria include native or valve-in-valve TAVR requiring single-leaflet modification.
- Severe commissural misalignment needing leaflet modification.
- High risk for coronary occlusion not suitable for leaflet modification.
- Critical low-flow low-gradient aortic stenosis with estimated valve area 0.5 cm2 or less.
You will not qualify if you...
- Age under 18 years or pregnancy.
- General absolute contraindications to TAVR.
- Severe peripheral artery disease preventing ECMO implantation.
- Contraindications to transseptal cannulation, such as a pre-existing interatrial septum occluder device.
- Use of pre-existing Impella treatment.
- Shock onset more than 12 hours prior.
- Prolonged cardiac arrest with resuscitation longer than 40 minutes.
- Severe other diseases with life expectancy less than 6 months.
- Participation in another trial involving an intervention.
- Any Class I hemodynamic status.
- Type A anatomical complexity with Class I or II hemodynamic status.
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - During the TAVR procedure and hospitalization (up to 30 days)
Participants undergo the pre-emptive placement of the Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO) device prior to or at the start of the high-risk transcatheter aortic valve replacement (TAVR) procedure to provide mechanical circulatory support and left ventricular unloading.
1 procedure visit and hospital stay (up to 30 days)
Trial Site Locations
Total: 2 locations
1
Center for Structural Heart Disease Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
2
Valve and Structural Heart Center Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
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Research Team
G
Gennaro Giustino, MD
P
Pedro Villablanca, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Severe aortic insufficiency-induced cardiogenic shock treated with left atrial VA-ECMO and emergent valve-in-valve TAVR.
Hafez Golzarian, Arielle Thiel, Gerri Hempfling...
https://pubmed.ncbi.nlm.nih.gov/37890858Feasibility and safety of transcaval venoarterial extracorporeal membrane oxygenation in severe cardiogenic shock.
Gennaro Giustino, Brian P O'Neill, Dee Dee Wang...
https://pubmed.ncbi.nlm.nih.gov/38629421Transcatheter interventions for left-sided valvular heart disease complicated by cardiogenic shock: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) in collaboration with the Association for Acute Cardiovascular Care (ACVC) and the ESC Working Group on Cardiovascular Surgery.
Chiara Fraccaro, Nicole Karam, Helge Möllmann...
https://pubmed.ncbi.nlm.nih.gov/37624587Left Atrial Venoarterial Extracorporeal Membrane Oxygenation for Patients in Cardiogenic Shock and Acute Aortic Regurgitation.
Pedro A Villablanca, Waleed Al-Darzi, Andrew Boshara...
https://pubmed.ncbi.nlm.nih.gov/36265949Left Atrial-Veno Arterial Extracorporeal Membrane Oxygenation as a Bridge to Surgery for Endocarditis-Related Acute Severe Aortic Regurgitation.
Aditya Sabharwal, Athanasios Tsiouris, Mark S Slaughter...
https://pubmed.ncbi.nlm.nih.gov/37913501Left Atrial-Veno-Arterial Extracorporeal Membrane Oxygenation: Step-By-Step Procedure and Case Example.
Alejandro Lemor, Mir B Basir, Brian P O'Neill...
https://pubmed.ncbi.nlm.nih.gov/37288119Percutaneous Retrieval of an Aortic Valve Vegetation Causing Severe Regurgitation and Cardiogenic Shock.
Claudia Lama von Buchwald, Pedro Engel Gonzalez, Brian O'Neill...
https://pubmed.ncbi.nlm.nih.gov/37140503LAVA-ECMO-Supported Dual-Transcatheter Aortic and Mitral Valve-in-Valve Replacement in Cardiogenic Shock.
Jonathan X Fang, Gennaro Giustino, Dimitrios Apostolou...
https://pubmed.ncbi.nlm.nih.gov/39484326Left Atrial Venoarterial Extracorporeal Membrane Oxygenation for Acute Aortic Regurgitation and Cardiogenic Shock.
Michael Chiang, Pedro E Gonzalez, Brian P O'Neill...
https://pubmed.ncbi.nlm.nih.gov/35257102