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

NCT06770023 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: 24-000660
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Survival until transplant

  Number of subjects to survive between placement of cannula and lung transplant.

  3 weeks

Secondary Outcomes (4)

• Number of subjects to experience adverse events

  2 months

• Extra-corporeal membrane oxygenation (ECMO) support

  2 months

• Dialysis

  2 months

• Hospital Discharge

  2 months

Study Arms (1)

Lung transplant patients

EXPERIMENTAL

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

Device: Protek Solo Transseptal Cannula

Interventions

Protek Solo Transseptal Cannula 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.

Lung transplant patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• central venous pressure (CVP) \> 15 mm Hg
• global RV dysfunction on echocardiography defined as one of the following:
• a tricuspid annular plane systolic excursion score of \<14mm

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Study Officials

• Ian Makey, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Mohammad E Alomari, MD

  Mayo Clinic

  STUDY DIRECTOR

Central Study Contacts

Ian A Makey, MD

CONTACT

9049531048; makey.ian@mayo.edu

Mohammad E Alomari, MD

CONTACT

9044283665; alomari.mohammad@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 13, 2025
• Study Start (Estimated): June 11, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)