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

NCT ID: NCT06770023

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-11
• Study Completion Date: 2028-12-31

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.

Conditions

Lung Transplant; Pulmonary Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lung transplant patients

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

Group Type: EXPERIMENTAL

Protek Solo Transseptal Cannula

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ian Makey

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian Makey, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Mohammad E Alomari, MD

Role: STUDY_DIRECTOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ian A Makey, MD

Role: CONTACT

makey.ian@mayo.edu

9049531048

Mohammad E Alomari, MD

Role: CONTACT

alomari.mohammad@mayo.edu

9044283665

Facility Contacts

Ian Makey, MD

Role: primary

makey.ian@mayo.edu

800-634-1417

Other Identifiers

24-000660

Identifier Type: -

Identifier Source: org_study_id