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

NCT05779787 | Recruiting

• 1 other identifier: D001024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• Coronary re-access after TAVR procedure

  Re-engagement of LMCA and RCA after valve implantation is defined as selective cannulation and subsequent selective angiography. All others type of re-engagement will be classify as "non selective". We will stratify also the modality of re-cannulation in relation to the position of the valves' stent struts as "above", "across" and "behind".

  During procedure

Secondary Outcomes (13)

• Total Implant Time

  During procedure

• Total Implant Fluoroscopy Time

  During procedure

• Total Implant Radiations

  During procedure

• Total Implant Contrast

  During procedure

• Alignment Radiation

  During procedure

Study Arms (2)

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

Procedure: TAVR Aligned; Procedure: TAVR Random

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

Procedure: TAVR Aligned; Procedure: TAVR Random

Interventions

TAVR Aligned PROCEDURE

Investigate the feasibility of coronary re-engagement after commissural alignment technique in terms of success rate (%) and procedure complexity taking into account radiations, time and contrast used.

TAVR performed with commissural alignment technique (Aligned Group); TAVR performed with random implantation of Navitor valve (Random Group)

TAVR Random PROCEDURE

TAVR Random Feasibility comparison of coronary re-engagement between the randomly implanted Navitor valve (unaligned) and the others implanted with the commissural alignment technique in terms of success rate (%) and complexity of the procedure, taking into account radiation, time and contrast used

TAVR performed with commissural alignment technique (Aligned Group); TAVR performed with random implantation of Navitor valve (Random Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with severe aortic stenosis diagnosed according to ESC guidelines, undergoing transcatheters aortic valve replacement with Navitor valve randomly implanted or Acurate Neo with commisural alignment technique

You may not qualify if:

• Patients excluded in this registry should have all the following criteria:
• Valve in Valve procedure
• Hemodynamical instability
• TAVR performed from other access (not femoral)
• No-CT Planned TAVR
• TAVR performed with Chimney Technique

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST GOM Niguarda

Milan, Lombardy, 20162, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Giuseooe Esposito, MD

CONTACT

+393278393131; giuseppe.esposito@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 22, 2023
• Study Start: February 15, 2023
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

IT (1)