COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)
Recruiting now
Conditions studied: Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
In brief
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.
Key facts
- Study ID
- NCT05779787
- Run by
- Niguarda Hospital
- People needed
- 100
- Starts
- 2023-02-15
- Expected to finish
- 2027-05-15
- Last updated by the study team
- 2026-04-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- ASST GOM Niguarda — Milan, Lombardy, Italy (enrolling)
Full record on ClinicalTrials.gov
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