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

Launched by NIGUARDA HOSPITAL · Mar 10, 2023

Keywords

ClinConnect Summary

The COMFORT STUDY is a clinical trial that is looking at a new way to help patients with a heart condition called aortic valve stenosis, which makes it hard for the heart to pump blood. This study is specifically looking at patients who are having a procedure called Transcatheter Aortic Valve Replacement (TAVR). The researchers want to find out if using a specific type of valve, called the Navitor valve, can make it easier for doctors to access the coronary arteries again if needed after the valve is placed. This is important because many patients also have coronary artery disease, and it’s crucial to ensure they can receive further treatment if necessary.

To participate in this study, patients need to be between the ages of 65 and 74 and have severe symptoms from aortic stenosis that require TAVR. However, certain patients will not be able to join, including those who have had previous heart valve procedures or have serious heart instability. Participants in the trial can expect to undergo the standard TAVR procedure, and their progress will be closely monitored to see how well they can access their coronary arteries afterwards. Overall, this study aims to simplify the process while ensuring patient safety and effective treatment options.

Gender

ALL

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