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Recruiting NCT05779787

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

Trial Parameters

Condition Aortic Valve Stenosis
Sponsor Niguarda Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-02-15
Completion 2026-02-15
Interventions
TAVR AlignedTAVR Random

Brief 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 Criteria

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

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