COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)
COronary Re-EngageMent aFter RandOm NavitoR Alignment (COMFORT STUDY)
Niguarda Hospital
100 participants
Feb 15, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Patients to be included in this registry should have all the following criteria:
- \. Severe, symptomatic aortic stenosis with an indication to TAVI
Exclusion Criteria6
- 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
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Interventions
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 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)
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NCT05779787