Actively Recruiting
COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)
Led by Niguarda Hospital · Updated on 2026-04-16
100
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe, symptomatic aortic stenosis with an indication for TAVI
You will not qualify if you...
- Valve-in-valve procedure
- Hemodynamical instability
- TAVR performed from other access (not femoral)
- No-CT planned TAVR
- TAVR performed with chimney technique
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ASST GOM Niguarda
Milan, Lombardy, Italy, 20162
Actively Recruiting
Research Team
G
Giuseooe Esposito, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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