Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension
A Pilot Study of Transseptal ECMO With the Protek Solo Cannula in Lung Transplant Candidates With Right Heart Failure From Pulmonary Hypertension
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether transseptal ECMO, a machine that supports the heart and lungs, can safely help people wait for a lung transplant. It is for adults whose right side of the heart is failing because of high blood pressure in the lungs.
The purpose of this study is to determine if transseptal extra-corporeal membrane oxygenation (ECMO) can bridge pulmonary hypertension- right heart failure (PH-RVF) patients to lung transplant safely.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be on the waiting list for a lung transplant.
- Have high blood pressure in the lung arteries: either Group 1, including Eisenmenger syndrome, or Group 3, linked to long-term lung disease or low oxygen. Heart pressure tests must meet the study’s limits.
- Have a right side of the heart that pumps too little blood despite high doses of heart-support medicines and inhaled nitric oxide.
- Have high pressure in the veins near the heart or an ultrasound showing poor right-heart function, based on the study’s limits.
- Have blood lactate above 3 mmol/L and urine output below 0.5 mL/kg/hour. These tests help show whether organs get enough blood.
- Be older than 18 and have a body mass index (BMI), a measure based on height and weight, below 35.
- Sign a consent form, or have a legally authorized person sign for you.
Who can't join
- Have the most severe heart-related shock, with life-threatening low blood pressure, rapidly increasing medicine needs, and too little blood reaching the organs.
- Have liver or kidney failure: bilirubin above 5 mg/dL or creatinine above 4 mg/dL on tests within 24 hours before ECMO starts.
- Have signs of a recent brain or nervous system injury.
- Have an active infection, shown by at least two of these: white blood cell count above 12,500, germs found in a blood sample, or fever.
- Have a blood clot in the right upper chamber of the heart.
- Have received clot-dissolving treatment in the past 30 days, or have a known blood-clotting problem or blood disease such as sickle cell anemia or thalassemia.
- Have right-heart failure caused only by a blood clot in the lungs, by disease in the heart’s arteries, or by failure of the left side of the heart.
- Have a form of high blood pressure in the lungs linked to a condition present at birth, such as tetralogy of Fallot or narrowed lung veins.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
FL
- Mayo Clinic in Florida · Jacksonville, FL 32224Ian Makey, MD · Study contact · 800-634-1417 · makey.ian@mayo.eduIan A Makey · Principal investigatorMore trials in Jacksonville