Tests a heart-lung support device in people awaiting lung transplant
Tests a device for heart support in adults with pulmonary hypertension awaiting transplant.
Plain-language title generated from the registry record
Registry title: Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension
Key facts
- Where
- Jacksonville, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06770023, who can take part
Where in United States
- Mayo Clinic in FloridaJacksonville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mayo Clinic
- Trial code
- NCT06770023
- Record updated
- 31 July 2026
- Original description
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.Read full original descriptionShow less
A Pilot Study of Transseptal ECMO With the Protek Solo Cannula in Lung Transplant Candidates With Right Heart Failure From Pulmonary Hypertension
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.
Inclusion: 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:; central venous pressure (CVP) > 15 mm Hg; global RV dysfunction on echocardiography defined as one of the following:; a tricuspid annular plane systolic excursion score of <14mm; an RV diameter at base >42mm; 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: 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; 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; Active infection defined as two of the following WBC >12,500, positive blood culture, fever; Thrombolysis within the previous 30 days or known existing coagulopathy such as thrombocytopenia or hemoglobin diseases such as sickle cell anemia or thalassemia; 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); Evidence of acute neurologic injury; RA thrombus.