Recruiting
Phase 1

ECMO

Sponsor:

Mayo Clinic

Code:

NCT06770023

Conditions

Lung Transplant

Pulmonary Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Protek Solo Transseptal Cannula

Study Details

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.

Conditions

Lung Transplant

Pulmonary Hypertension

Study ID

NCT06770023

Start date

Dec 11, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

4 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lung transplant patients

Subjects will be those who are on the transplant list and progress to needing right ventricle (RV) support

Interventions

Protek Solo Transseptal Cannula

The Protek Solo Transseptal Cannula ECMO cannula will be placed from the right femoral vein and the drainage cannula will be placed from either the left femoral vein or the right internal jugular vein.

Primary outcome measure

  • Survival until transplant [ Time Frame: 3 weeks ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Principal Investigator:

Ian A Makey

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • right heart failure, transseptal, extra-corporeal membrane oxygenation, bridge to transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-31. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.