COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)

Whereas PCI before TAVR was previously recommended despite its uncertain prognostic role, recent data underline the possibility of a postponed coronary intervention using a commissural alignment technique. This approach allows easy coronary re-engagement through the valve stent frame with a trade off paid of procedure complexity. Considering the prevalence of coronary artery disease (CAD) and the increasing percentage of younger patients treated with TAVI, investigate whether a simpler procedure with random implantation of Navitor valve is not inferior in terms of coronary re-access, is required The key point of the project will be the evaluation of the feasibility of coronary re-engagement after a Navitor valve randomly implanted.

NCT Number	NCT05779787
Lead Sponsor	Niguarda Hospital
Conditions	Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Enrollment	100 participants
Start Date	2023-02-15
Primary Completion	2027-02-15 (estimated)
Study Completion	2027-05-15 (estimated)
Updated on ClinicalTrials.gov	2026-04-16