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Completed

NCT Number: NCT04906837

Pre TAVI Membranous Septum Measurement Predicts High Grade Iatrioventricular Conduction Disorders in Patients With Specific Pacemaker Implanted After TAVI. The STIM TAVI-MS Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Annecy Genevois

Annecy, 74370, France

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old
  • Patients included in the STIM TAVI study with full follow-up (not excluded from STIM TAVI for lack of data)
  • Patients who did not object to the use of CT and angiography data

Exclusion criteria

  • Oral opposition to participate

Treatment and study plan

Trans aortic valve implantation

Diagnostic Test

Measurement of the membranous septum on the pre TAVI scanner and the valve implantation height

Primary outcomes

  1. One late high-grade AVB

    Time frame: between day 7 to one year

    Presence of at least one late high-grade AVB episode

Secondary outcomes

  1. CT and angiographic measurements,

    Time frame: one year

    Feasibility of CT and angiographic measurements,

  2. intra and inter observer variability

    Time frame: one year

    intra and inter observer variability.

Sponsors and collaborators

Lead sponsor

Association de Recherche en Cardiologie des Alpes

Other

Registry information

Acronym: STIM TAVI MS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 28, 2021
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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