UnknownNot Applicable

STIMTAVI : Evolution of Atrioventricular Conduction Disorders After TAVI

275 participantsStarted 2015-11-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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)

Trial details

NCT IDNCT03338582

SponsorAssociation de Recherche en Cardiologie des Alpes

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-01-19

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