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

NCT05779787 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-04-16

No results posted yet for this 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.

Conditions

  • Aortic Valve Stenosis
  • Transcatheter 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

Sponsors & Collaborators

  • Niguarda Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2027-02-15
Completion
2027-05-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05779787 on ClinicalTrials.gov