Evaluating coronary re-engagement after TAVR with a Navitor valve

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

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 type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Niguarda Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Milan, Lombardy)
• Trial ID: NCT05779787 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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 performed: 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.

Eligibility 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 this trial is running

Milan, Lombardy

• ASST GOM Niguarda — Milan, Lombardy, Italy (Recruiting)

Study contacts

• Study coordinator: Giuseooe Esposito, MD

Conditions Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement