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

Mayo Clinic

Status and phase

Enrolling

Phase 1

Conditions

Lung Transplant

Pulmonary Hypertension

Treatments

Device: Protek Solo Transseptal Cannula

Study type

Interventional

Funder types

Other

Identifiers

NCT06770023

24-000660

Details and patient eligibility

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.

Full description

Results will be released as a manuscript once it has gone through the peer review process. Results will be released even in the event of negative outcomes and the release will be hastened if the study is terminated early.

Medicare beneficiaries may be affected by the device under investigation if they are candidates for lung transplant. Since this is such a select group of patients, we do not expect the results of this trial to be generalizable to the general Medicare population.

Enrollment

4 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.