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

NCT05779787 · tracked via the Priya Life Science Italy tracker

Sponsor

Niguarda Hospital

Phase

Observational

Started

2023-02-15

Last updated

2026-04-16

Condition(s) studied

Aortic Valve StenosisTranscatheter Aortic Valve Replacement

Investigational drug(s) / intervention(s)

TAVR AlignedTAVR Random

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.

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

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Coronary re-access after TAVR procedure — During procedure
Re-engagement of LMCA and RCA after valve implantation is defined as selective cannulation and subsequent selective angiography. All others type of re-engagement will be classify as "non selective". We will stratify also the modality of re-cannulation in relation to the position of the valves' stent struts as "above", "across" and "behind".

Trial sites (1)

Facility	City	Region	Status
ASST GOM Niguarda	Milan	Lombardy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05779787 on ClinicalTrials.gov ↗ ← All trials in Italy