Actively Recruiting

Phase 1
Age: 18Years - 80Years
All Genders
NCT06770023

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

Led by Mayo Clinic · Updated on 2026-03-31

4

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients listed for lung transplantation
  • Pulmonary hypertension defined as Group 1 Pulmonary arterial hypertension with mean pulmonary artery pressure ≥ 20 mm Hg, pulmonary capillary wedge pressure < 15 mm Hg, and pulmonary vascular resistance ≥ 3 Wood units
  • Group 3 pulmonary hypertension defined by presence of chronic lung disease and/or hypoxia with mean pulmonary artery pressure ≥ 20 mm Hg
  • Diagnosis of secondary PH (WHO Group 3) or primary PH (WHO Group 1), including Eisenmenger syndrome
  • Failing right ventricular function indicated by cardiac index < 2.2 L/min/m² despite continuous high dose inotropes and inhaled nitric oxide > 20 ppm with specific inotrope dosing criteria
  • One of the following: central venous pressure > 15 mm Hg, or global right ventricular dysfunction on echocardiography with specific measurement criteria
  • Lactate level greater than 3 mmol/L
  • Urine output less than 0.5 ml/kg/hour
  • Age over 18 years
  • Body mass index under 35
  • Signed informed consent by self or legally authorized representative
Not Eligible

You will not qualify if you...

  • INTERMACS 1 patients with critical cardiogenic shock and life-threatening hypotension
  • End organ failure with hepatic total bilirubin > 5 mg/dL within 24 hours prior to ECMO initiation
  • Renal creatinine > 4 mg/dL within 24 hours prior to ECMO initiation
  • Evidence of acute neurologic injury
  • Active infection defined by two of the following: WBC > 12,500, positive blood culture, or fever
  • Right atrial thrombus
  • Thrombolysis within previous 30 days or known coagulopathy such as thrombocytopenia or hemoglobin diseases like sickle cell anemia or thalassemia
  • Right heart failure caused by isolated pulmonary embolism
  • Right heart failure caused by coronary artery disease or left heart failure (WHO Type 2)
  • Congenital pulmonary hypertension such as tetralogy of Fallot or pulmonary vein stenosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224

Actively Recruiting

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Research Team

I

Ian A Makey, MD

CONTACT

M

Mohammad E Alomari, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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