Clinical trial Recruiting at 1 site Observational Ages 18 and up

Evaluating coronary re-engagement after TAVR with a Navitor valve

Official title: COronary Re-EngageMent aFter RandOm NavitoR Alignment (COMFORT STUDY)

Run by Niguarda Hospital · NCT05779787 · Data updated 2026-11-12

This study is testing if a new way of placing a heart valve during TAVR can help doctors still access the coronary arteries for patients who have both aortic stenosis and coronary artery disease.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorNiguarda Hospital
Academic / other
Drugs / interventionsradiation
Locations1 site (Milan, Lombardy)
StatusRecruiting
StartedFebruary 15, 2023
Main results expectedFebruary 15, 2027
Study endsMay 15, 2027
Registry record updatedApril 16, 2026
Trial IDNCT05779787 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with severe, symptomatic aortic stenosis who are indicated for TAVI.

Probably not a fit

Patients who have undergone a Valve in Valve procedure or have hemodynamical instability will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the feasibility of coronary re-engagement following the implantation of a Navitor valve during Transcatheter Aortic Valve Replacement (TAVR) procedures. It aims to determine whether a random implantation technique can maintain effective access to coronary arteries, which is crucial for patients with pre-existing coronary artery disease. The study will assess the outcomes of patients with severe symptomatic aortic stenosis who undergo TAVR, focusing on the procedural complexity and the potential for unplanned coronary interventions. By comparing aligned versus random valve placements, the study seeks to provide insights into optimizing TAVR procedures for better patient outcomes.

Why it matters

Potential benefit: If successful, this study could simplify TAVR procedures and improve access to coronary interventions for patients with aortic stenosis.

How similar studies have gone: While the approach of using commissural alignment techniques is emerging, this specific study's methodology is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • ASST GOM Niguarda
    Milan, Lombardy, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.