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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNiguarda Hospital

About this trial

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

Qualifiers

None

Disqualifiers

Valve in Valve procedure

Hemodynamical instability

TAVR performed from other access (not femoral)

No-CT Planned TAVR

Trial design

Treatments tested in this trial

  • TAVR Aligned
  • TAVR Random

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators