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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients to be included in this registry should have all the following criteria:

• 1\. Severe, symptomatic aortic stenosis with an indication to TAVI

Locations
Other Locations
Italy
ASST GOM Niguarda
RECRUITING
Milan
Contact Information
Primary
Giuseooe Esposito, MD
giuseppe.esposito@yahoo.com
+393278393131
Time Frame
Start Date: 2023-02-15
Estimated Completion Date: 2027-05-15
Participants
Target number of participants: 100
Treatments
TAVR performed with commissural alignment technique (Aligned Group)
Patients with severe aortic stenosis undergoing TAVR procedure performed with commissural alignment technique. We consider in this groups only the Accurate and Accurate Neo 2 Valve which are the first choice due to the best stent frames position predictability with this technique
TAVR performed with random implantation of Navitor valve (Random Group)
Patients with severe aortic stenosis undergoing TAVR procedure performed with random implantation of Navitor Valve
Sponsors
Leads: Niguarda Hospital

This content was sourced from clinicaltrials.gov