NCT05779787View on ClinicalTrials.gov

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

RecruitingOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

February 15, 2023

Primary Completion Date

February 15, 2026

Study Completion Date

May 15, 2027

Conditions
Aortic Valve StenosisTranscatheter Aortic Valve Replacement
Interventions
PROCEDURE

TAVR Aligned

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.

PROCEDURE

TAVR Random

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

Trial Locations (1)

20162

RECRUITING

ASST GOM Niguarda, Milan

All Listed Sponsors
lead

Niguarda Hospital

OTHER