STIMTAVI : Evolution of Atrioventricular Conduction Disorders After TAVI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-01

Study Completion Date

2018-04-19

Brief Summary

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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

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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.

Conditions

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Pacemaker Implantation TAVI

Keywords

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Pacemaker Conduction disturbance TAVI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Didier IRLES, Dr

Role: STUDY_DIRECTOR

Association de Recherche en Cardiologie des Alpes

References

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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.

Reference Type DERIVED

PMID: 33625762 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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ARCAlpes

Identifier Type: -

Identifier Source: org_study_id