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Heart-Lung machine may shield High-Risk patients during valve procedure

NCT ID NCT07309029

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 100 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Center for Structural Heart Disease Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Valve and Structural Heart Center Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07960, United States

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Other studies related to the condition(s) this trial covers.