New ECMO technique aims to bridge lung transplant patients safely to surgery
NCT ID NCT06770023
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This early-stage study tests a new way to use a heart-lung machine (ECMO) in 4 people waiting for a lung transplant who also have heart failure from high blood pressure in the lungs. The goal is to see if this approach can keep them alive and stable until they receive a transplant. The study focuses on safety and survival, not on curing the underlying disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 4 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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.
- Ages
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18 to 80 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Patients that are listed for lung transplantation and have: * PH defined as: * Group 1 Pulmonary arterial hypertension (PAH): Mean pulmonary artery pressure (PAP) ≥ 20 mm Hg, pulmonary capillary wedge pressure (PCWP) \< 15 mm Hg, and pulmonary vascular resistance (PVR) ≥ 3 Wood units * Group 3 PH is defined as the presence of chronic lung disease (CLD) and/or hypoxia and mean pulmonary artery pressure (PAP) ≥ 20 mm Hg. * Secondary PH (WHO Group 3) or diagnosis of primary PH (WHO Group 1) (to include Eisenmenger syndrome). * Failing right ventricle function defined as: * a cardiac (CI) index \< 2.2 L/min/m\^2 despite continuous infusion of high dose inotropes defined as: * Inhaled nitric oxide \> 20 ppm and one of the following: * Dobutamine \> 10 ug/kg/min x 15 minutes or * Milrinone \> 0.5 ug/kg/min x 120 minutes or * Epinephrine \> 0.5 ug/kg/min x 15 minutes or * Norepinephrine \> 0.5 ug/kg/min x 15 minutes and have one of the following: 1. central venous pressure (CVP) \> 15 mm Hg 2. global RV dysfunction on echocardiography defined as one of the following: 1. a tricuspid annular plane systolic excursion score of \<14mm 2. an RV diameter at base \>42mm 3. RV short-axis or midcavity diameter \>35mm * Lactate greater than 3 mmol/L * Urine output \< 0.5 ml/kg/hour * Age \> 18 years old * BMI \<35 * Informed consent signed by self or legally authorized representative. Exclusion Criteria * INTERMACS 1 patients (Critical cardiogenic shock patient who is "crashing and burning", has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels) * End organ failure defined as: hepatic total bilirubin \>5 mg/dL based on lab data within 24 hours prior to transseptal ECMO initiation; renal creatinine \>4 mg/dLbased on lab data within the 24 hours prior to transseptal ECMO initiation * Evidence of acute neurologic injury * Active infection defined as two of the following WBC \>12,500, positive blood culture, fever * RA thrombus * Thrombolysis within the previous 30 days or known existing coagulopathy such as thrombocytopenia or hemoglobin diseases such as sickle cell anemia or thalassemia * Right heart failure from isolated pulmonary embolism * Right heart failure from coronary artery disease or from left heart failure (WHO Type 2) * Congenital forms of pulmonary hypertension such as tetralogy of fallot or pulmonary vein stenosis.
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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
1 site. 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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Mayo Clinic in Florida
RECRUITINGJacksonville, Florida, 32224, United States
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Other studies related to the condition(s) this trial covers.
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