Clinical trial NCT03338582: STIMTAVI : Evolution of Atrioventricular Conduction Disorders After TAVI
Official title: STIMulation Cardiaque et TAVI : évolution Des Troubles Conductifs Atrio-ventriculaires après TAVI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pacemaker Implantation
TAVI
Keywords: Pacemaker
Conduction disturbance
TAVI
Lead sponsor: Association de Recherche en Cardiologie des Alpes
Sponsor class: OTHER
Collaborators: name: LivaNova
First posted: 2017-11-09
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 275 patients over 18 years who underwent implantation of a TAVI and that were implanted during the hospitalization with a dual chamber pacemaker Sorin®, set in AAI SafeR ® or AAI SafeR-R® mode.

Brief summary: The investigators propose to carry out an observational study of patients implanted with a pacemaker using AAI SafeR® mode after a TAVI procedure. This study aims to define the persistence or not of high-grade AVB beyond seven days after the procedure, based on the analysis of PM memories, and define definitive cardiac pacing indications after TAVI procedure.

Detailed description: Atrioventricular (A-V) conduction disorders are common after Transcatheter Aortic Valve Implantation (TAVI) and the average of a pacemaker implantation after TAVI is 15% to 17%.

The European Society of Cardiology recommends to implant a permanent pacemaker (PM) in case of persistant high-grade A-V block (AVB) within 7 days of a TAVI procedure (class I recommendation, level of evidence C).

Some conduction disturbances are transient and might not need a definitive indication for pacemaker implantation. A recent study, based on dependency of patients to pacing, estimate that in half the patients, conduction disturbances that led to the implantation of a pacemaker after TAVI procedure would have disappear 30 days after the procedure.

Many studies tried to better define the indications of these devices. However, their evaluation criteria do not allow to prove these pacemakers were useful, because these studies are mainly based on the rate of implantation of pacemakers, or on the percentage of ventricular pacing. These studies may overestimate the usefulness of the pacemaker because of unnecessary ventricular pacing, or underestimate it in patients with high grade paroxysmal AVB, that could have been responsible for syncope or death.

Today some pacemakers allow a better occurrence of spontaneous A-V conduction and monitor precisely the atrioventricular conduction.

The AAI SafeR® mode from Sorin® allows the pacemaker to switch from a single to a dual chamber mode in case of AVB; these switches are stored in the memories of PM as endocardial electrogram (EGM) which can be validated afterwards. The use of this algorithm could allow an accurate assessment of the persistence of high level conduction disturbances in patients implanted with a pacemaker after a TAVI procedure. A study published in late 2014 using this tool in monitoring post TAVI conduction disorders on a small number of patients, other studies used the same tool in other cardiac pathologies.

Eligibility criteria: Inclusion Criteria:

* All patients over 18 years who underwent implantation of a TAVI and that were implanted during the hospitalization with a dual chamber pacemaker Sorin®, set in AAI SafeR ® or AAI SafeR-R® mode.

Exclusion Criteria:

* Patients with life expectancy at hospital discharge estimated as less than 1 year
* TAVI procedure failure
* Patients refusing to be involved in the study
* Patients implanted with a PM of a brand different than Sorin® during the hospital phase or implanted Sorin® PM but not set in a AAI or AAI SafeR SafeR-R mode
* Patients with PM implant before TAVI
* Permanent AF at the implantation time
* Patients with Single or Triple chamber PM

Primary outcomes:
measure: To look for one or several high level A-V block episodes beyond seven days after a TAVI procedure, by the analysis of the EKG and of the pacemaker memories during the follow-up visits
timeFrame: Until the completion of the study (first follow-up visit 1 to 3 months after TAVI, last follow-up visit 1 year after TAVI)
Secondary outcomes:
measure: To study the influence of certain predefined factors on the risk of high-level A-V block after a TAVI procedure.
timeFrame: An average of 8 days (from the day before the TAVI procedure to 7 days after TAVI)
Other outcomes:
Locations:
Study officials:
affiliation: Association de Recherche en Cardiologie des Alpes
name: Didier IRLES, Dr
role: STUDY_DIRECTOR
References:
citation: Irles D, Salerno F, Cassagneau R, Eschalier R, Maupain C, Dupuis JM, Mansourati J, Guedon L, Marijon E, Frey P; Other members of the STIMulation cardiaque post-TAVI (STIM-TAVI) study. Evolution of high-grade atrioventricular conduction disorders after transcatheter aortic valve implantation in patients who underwent implantation of a pacemaker with specific mode-that minimizes ventricular pacing-activated. J Cardiovasc Electrophysiol. 2021 May;32(5):1376-1384. doi: 10.1111/jce.14970. Epub 2021 Mar 4.