Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05779787 |
| Other study ID # |
D001024 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2023 |
| Est. completion date |
May 15, 2027 |
Study information
| Verified date |
March 2024 |
| Source |
Niguarda Hospital |
| Contact |
Giuseooe Esposito, MD |
| Phone |
+393278393131 |
| Email |
giuseppe.esposito[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Transcatheter Aortic Valve Implantation (TAVI) is recommended by European and American
guidelines to treat patients with aortic stenosis regardless of procedural risk (1, 2). In
the last decades the increasing percentage of younger patients treated with TAVI, reflect the
extensive indications in lower risk setting, highlighting the importance of easy coronary
re-engagement after valve implantation. Considering the prevalence and the progression of a
pre-existing coronary artery disease (CAD), the timing of coronary intervention should be
accurate selected (3) addressing the percentage of unplanned percutaneous coronary
intervention (PCI) after TAVI (4). In fact, while PCI before TAVR was previously recommend
despite the uncertain prognostic role (5), recent data remarks the possibility of a postponed
coronary intervention using a commissural alignment technique (6) that allows a predictable
stent frame position in the sinus of Valsalva (7). Moreover, following the emerging concept
of easy re-access, only a few types of prostheses have been shown to have an high degree of
stent position predictability after implantation, leading to a limited option in terms of
prosthesis choice. Furthermore, to achieve the best results with commissural alignment
technique, accurate procedure planning and operator's expertise are required in order to
properly manage the valve specific orientation in the aorta with consequent increase in time,
radiation and procedure complexity.
However, geometry of the stent frame (height and size) and the anatomical characteristics of
patients have to be enlisted as contributory factors to difficult coronary re-engagement and
need to be evaluate in order to establish the feasibility of the re-access after TAVR.
The investigators' findings could provide data regarding the non-inferiority rate of coronary
cannulation after a simpler procedure with Navitor implantation without alignment technique.
Due to these results, the valves portfolio available in patients with coronary artery disease
that needed PCI after TAVR, could be larger and various allowing the best protheses choice
according to the patient's anatomy and operator's expertise. Finally, knowing the predictors
of difficult re-engagement for both types of valves, regardless of implantation technique,
could be interesting for an even more valve tailored approach.
The purpose of this study is to investigate the feasibility of coronary re-engagement after
randomly (not aligned) Navitor implantation, as already perform in current clinical practice,
due to a lower predictable orientation of this type of valve.
