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Recruiting NCT06770023

Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension

Conditions: Lung Transplant, Pulmonary Hypertension

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 4
Sponsor: Mayo Clinic

Location: Mayo Clinic in Florida Jacksonville Florida

Summary

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.

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 \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 \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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06770023). StuddyBuddy aggregates publicly available trial information.