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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
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.
Mayo Clinic in Florida
Jacksonville, Florida, United States
RECRUITINGSurvival 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
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