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COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)
Sponsor: Niguarda Hospital
Summary
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.
Official title: COronary Re-EngageMent aFter RandOm NavitoR Alignment (COMFORT STUDY)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2023-02-15
Completion Date
2027-05-15
Last Updated
2024-03-21
Healthy Volunteers
No
Interventions
TAVR Aligned
Investigate the feasibility of coronary re-engagement after commissural alignment technique in terms of success rate (%) and procedure complexity taking into account radiations, time and contrast used.
TAVR Random
TAVR Random Feasibility comparison of coronary re-engagement between the randomly implanted Navitor valve (unaligned) and the others implanted with the commissural alignment technique in terms of success rate (%) and complexity of the procedure, taking into account radiation, time and contrast used
Locations (1)
ASST GOM Niguarda
Milan, Lombardy, Italy