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RecruitingNCT06770023Updated Jul 31, 2026

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

A Phase 1 interventional study of Protek Solo Transseptal Cannula in Lung Transplant and Pulmonary Hypertension, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Transplant
  • Pulmonary Hypertension

Keywords

  • right heart failure, transseptal, extra-corporeal membrane oxygenation, bridge to transplant
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's planned enrollment of 4 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 669 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceProtek 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.

06

What researchers measure

Primary outcomes

  1. Survival until transplant

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

    Time frame: 3 weeks

Secondary outcomes

  1. 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.

    Time frame: 2 months

  2. Extra-corporeal membrane oxygenation (ECMO) support

    Number of days after transplant on ECMO support

    Time frame: 2 months

  3. Dialysis

    Number of subjects who need dialysis after transplant

    Time frame: 2 months

  4. Hospital Discharge

    Number of patients that are successfully discharged from the hospital

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224, United States
    • Ian Makey, MD · Contact · makey.ian@mayo.edu · 800-634-1417
    • Ian A Makey · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06770023
Lead sponsor
Mayo Clinic
Responsible party
Ian Makey (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jan 13, 2025
Start date
Dec 11, 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 31, 2026

Study contacts

Ian A Makey, MD
Contact
makey.ian@mayo.edu
9049531048
Mohammad E Alomari, MD
Contact
alomari.mohammad@mayo.edu
9044283665
Ian Makey, MD
principal investigator · Mayo Clinic
Mohammad E Alomari, MD
study director · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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