COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)

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

Patients to be included in this registry should have all the following criteria:

1\. Severe, symptomatic aortic stenosis with an indication to TAVI

Exclusion criteria and definition

Patients excluded in this registry should have all the following criteria:

1. Valve in Valve procedure
2. Hemodynamical instability
3. TAVR performed from other access (not femoral)
4. No-CT Planned TAVR
5. TAVR performed with Chimney Technique

Conditions3

Browse More Trials