Clinical trial NCT06770023: Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension
Official title: A Pilot Study of Transseptal ECMO With the Protek Solo Cannula in Lung Transplant Candidates With Right Heart Failure From Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lung Transplant
Pulmonary Hypertension
Keywords: right heart failure, transseptal, extra-corporeal membrane oxygenation, bridge to transplant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Survival until transplant
timeFrame: 3 weeks
Secondary outcomes:
measure: Number of subjects to experience adverse events
timeFrame: 2 months
measure: Extra-corporeal membrane oxygenation (ECMO) support
timeFrame: 2 months
measure: Dialysis
timeFrame: 2 months
measure: Hospital Discharge
timeFrame: 2 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Ian Makey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Mohammad E Alomari, MD
role: STUDY_DIRECTOR
References: