Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04906837 |
| Other study ID # |
AlpinARC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 20, 2020 |
| Est. completion date |
February 26, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
Association de Recherche en Cardiologie des Alpes |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Conduction disturbances are a major complication of TAVI. There is no predictor of post-TAVI
conduction disorder. The study of the membranous septum on the pre-TAVI scanner and the valve
implantation height are promising and little studied data on the occurrence of post-TAVI
conduction disorders.
Description:
After being developed for the treatment of aortic stenosis in inoperable patients, trans
aortic valve implantation (TAVI) techniques and devices have gradually improved, and its use
can now be considered in low-risk populations. . However, the need for pacemaker implantation
after TAVI remains one of the most common complications, and this issue needs to be addressed
before further expanding the TAVI indications.
Implantation of PM after TAVI is associated with increased morbidity and mortality, and there
are no formal predictors of these conduction disturbances. Some studies suggest that the
existence of preoperative conduction disturbances (eg, right bundle branch block or 1st
degree AVB) are associated with greater PM implantation or greater reliance on ventricular
pacing.
Other studies have focused on anatomical measurements such as the height of the membranous
septum obtained on the pre TAVI scanner, calcifications of the aortic ring and the depth of
the valve implantation obtained on the angiography of the TAVI procedure. . The depth of
valve implantation in relation to the height of the membranous septum would be a predictor of
conduction disorders and PM implantation post TAVI.
Anatomically, the left branch of the bundle of HIS originates approximately 6 mm below the
aortic annulus. Implantation of TAVI can affect the conduction tissues and lead to conduction
abnormalities where the penetrating portion of the HIS emerges on the surface of the LV
flushing chamber. The farther away the emerging part of the HIS is from the ring, the less
likely it is that an implant will encroach on it, and impair conduction.
Because the emerging part of the bundle of His is "sandwiched" between the membranous septum
and the posterior crest of the muscular septum, the lower end of the membranous septum
provides an anatomical landmark for the left ventricular exit point of the bundle of His,
with the length of the membranous septum equivalent to the distance aortic ring - bundle of
HIS.
The STIM TAVI study showed that 30% of patients implanted with a post-TAVI pacemaker did not
have high-grade AVB beyond 7 days post-implantation. Patients with early AVB (D1-D7) were at
high risk of developing late AVB. The study did not identify a population at low risk of
late-onset AVB, nor any pre-TAVI clinical or paraclinical criteria predictive of post-TAVI
AVB.
The study of the anatomy of the membranous septum and the height of implantation of the
aortic prosthesis in the STIM TAVI population would make it possible to analyze new
predictive criteria for late AVB (after D7).
