Heart-Lung machine may shield High-Risk patients during valve procedure
NCT ID NCT07309029
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using a heart-lung machine (ECMO) before a high-risk aortic valve replacement can prevent death, cardiac arrest, or emergency surgery. It includes 30 adults with severe aortic stenosis who are unstable or have complex anatomy. Participants receive ECMO support during the procedure and are followed for one year.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Study participants will be recruited from Atlantic Health System hospitals and affiliated centers. Eligible individuals are adult patients diagnosed with severe native aortic stenosis or degenerated bioprosthetic aortic valves who are scheduled for transcatheter aortic valve replacement (TAVR). Patients are identified through institutional clinical practices and referrals, including those admitted to the cardiac care unit with signs of hemodynamic instability or anatomical complexity. Recruitment may include critically ill patients who are sedated or intubated, with consent obtained from legally authorized representatives when necessary.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Center for Structural Heart Disease Henry Ford Hospital
RECRUITINGDetroit, Michigan, 48202, United States
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Valve and Structural Heart Center Morristown Medical Center
RECRUITINGMorristown, New Jersey, 07960, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Heart pump timing put to the test in deadly heart attack shock
- Can a new heart valve keep future artery access open?
- A second chance for the heart: can rehab rewrite the story after shock?
- Blood filter may calm the deadly inflammation of cardiogenic shock
- Microscopic blood vessel health may hold key to cardiogenic shock survival