Novel Lung Trial

Full Title

Normothermic Ex Vivo Lung Perfusion (EVLP) as an Assessment of Extended/Marginal Donor LungNovel

Goals:

The safety of perfusing extended donor lungs using the XPS with STEEN solution Perfusate prior to transplantation to evaluate and recondition donor lungs and thereby safely increase the donor lung pool.  This is an amendment and extension of the NOVEL trial to satisfy the (HDE) post approval study (PAS) and PMA study requirements.  This data will be used to support post approval safety monitoring and in support of PMA submission. 

Primary endpoints:
1.       12 month mortality
2.       Primary Lung Graft Dysunction (PGD) at 72 hours.
 
Secondary endpoints:
1.       FeV1 at 3, 6,. 9 months and 1 year: 2. PGD score at 24 and 48 hours.
2.       ICU length of stay.
3.       Hospital length of stay.
4.       Use of ECMO due to lung function post-transplant.
5.       Duration of mechanical ventilation post-transplant.
6.       Quality of life and functional status at 1 year.

 

Investigator(s)

Division(s)

Research Type

Contact Information

Diana Zaldonis
(412) 647-8323