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
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.
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.
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 →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.
Patients that are listed for lung transplantation and have:
PH defined as:
Failing right ventricle function defined as:
Norepinephrine > 0.5 ug/kg/min x 15 minutes and have one of the following:
global RV dysfunction on echocardiography defined as one of the following:
Exclusion Criteria
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.
Survival until transplant
Number of subjects to survive between placement of cannula and lung transplant.
Time frame: 3 weeks
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
Extra-corporeal membrane oxygenation (ECMO) support
Number of days after transplant on ECMO support
Time frame: 2 months
Dialysis
Number of subjects who need dialysis after transplant
Time frame: 2 months
Hospital Discharge
Number of patients that are successfully discharged from the hospital
Time frame: 2 months
Plan to share: No
No publications or documents are linked to this record.
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