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Bridge to Lung Transplant with Protek Solo Transseptal Cannula ECMO for Right Heart Failure

This study is looking at whether a device called the Protek Solo Transseptal Cannula can help patients with pulmonary hypertension (high blood pressure in the lungs) and right heart failure safely get to a lung transplant. The Protek Solo Transseptal Cannula is used for a type of life support called ECMO (extra-corporeal membrane oxygenation), which helps the heart and lungs. You might be able to join if you are between 18 and 80 years old, are already on the list for a lung transplant, and have specific types of pulmonary hypertension. The main goal of the study is to see if patients survive until their transplant, measured at 3 weeks. The study plans to enroll 4 patients, and its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 4 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, survival until transplant, is measured at 3 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06770023

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

Recruiting
PHASE1Ages 18–80InterventionalTreatment
Mayo Clinic
~4 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Protek Solo Transseptal Cannula

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Survival until transplant
Measured over 3 weeks

Conditions

Lung Transplant
Pulmonary Hypertension

Explore related trials

Pulmonary HypertensionRight Heart Failure

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Ian Makey, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Mohammad E Alomari, MD · STUDY_DIRECTOR · Mayo Clinic

Who to contact

Ian A Makey, MD
[email protected]
9049531048
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

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.

What this trial measures

  • Survival until transplant3 weeks

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