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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Niguarda Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milan, Lombardy) |
| Status | Recruiting |
| Started | February 15, 2023 |
| Main results expected | February 15, 2027 |
| Study ends | May 15, 2027 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT05779787 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
- Study coordinator: Giuseooe Esposito, MD
- Email: giuseppe.esposito@yahoo.com
- Phone: +393278393131
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluation of the Point-Guard device during heart valve replacement
This study is testing a new device called Point-Guard to see if it can help prevent brain problems during heart valve replacement surgery.
-
Evaluating the SAPIEN 3 Ultra RESILIA Valve for Aortic Stenosis
This study tests how well the new SAPIEN 3 Ultra RESILIA valve works for people with severe aortic stenosis who are getting a heart valve replacement, by checking its performance over the next 10 years.
-
Assessing ischemic and bleeding risks after TAVR
This study looks at the risks of bleeding and heart problems in patients getting a new heart valve through TAVR to see how to best tailor their blood-thinning treatment.
-
Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring
This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.
-
SYMmetric Valve expansion to reduce hypoattenuated leaflet thickening after balloon-expandable TAVI
This trial tests whether the Double-TAP post-dilatation strategy can reduce HALT and improve valve function in patients 70 or older undergoing balloon-expandable TAVI.
-
Vericiguat to slow calcific aortic valve narrowing
This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.