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

A Pilot Study of Transseptal ECMO With the Protek Solo Cannula in Lung Transplant Candidates With Right Heart Failure From Pulmonary Hypertension

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension; Lung Transplant
• Intervention / Treatment: Device: Protek Solo Transseptal Cannula

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.

• Study Type: Interventional
• Enrollment (Estimated): 4
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ian A Makey, MD; Phone Number: 9049531048; Email: makey.ian@mayo.edu
• Study Contact Backup: Name: Mohammad E Alomari, MD; Phone Number: 9044283665; Email: alomari.mohammad@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic in Florida
      • Contact: Ian Makey, MD; Phone Number: 800-634-1417; Email: makey.ian@mayo.edu
      • Principal Investigator: Ian A Makey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lung transplant patients; Subjects will be those who are on the transplant list and progress to needing right ventricle (RV) support	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival until transplant	Number of subjects to survive between placement of cannula and lung transplant.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects to experience adverse events	Adverse events are defined as: death, major bleeding, failure to achieve left atrium access, device migration and stroke.	2 months
Extra-corporeal membrane oxygenation (ECMO) support	Number of days after transplant on ECMO support	2 months
Dialysis	Number of subjects who need dialysis after transplant	2 months
Hospital Discharge	Number of patients that are successfully discharged from the hospital	2 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ian Makey, MD, Mayo Clinic; Study Director: Mohammad E Alomari, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): June 11, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: right heart failure, transseptal, extra-corporeal membrane oxygenation, bridge to transplant
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Heart Failure; Hypertension, Pulmonary
• Other Study ID Numbers: 24-000660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No