COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)
Key facts
- Where
- Milan, ItalySee the site
Where in Italy
- ASST GOM NiguardaMilan, ItalyContact: Giuseppe Esposito, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Niguarda Hospital
- Trial code
- NCT05779787
- Record updated
- 16 April 2026
- Original description
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.Read full original descriptionShow less
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.
Exclusion: Patients excluded in this registry should have all the following criteria:; Valve in Valve procedure; Hemodynamical instability; TAVR performed from other access (not femoral); No-CT Planned TAVR; TAVR performed with Chimney Technique.
Patients to be included in this registry should have all the following criteria:; Severe, symptomatic aortic stenosis with an indication to TAVI.