Clinical Trials Logo
  1. Home
  2. Pacemaker Implantation
  3. NCT03338582

STIMTAVI : Evolution of Atrioventricular Conduction Disorders After TAVI — STIMTAVI  

TAVI Clinical Trial

Official title:
STIMulation Cardiaque et TAVI : évolution Des Troubles Conductifs Atrio-ventriculaires après TAVI

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03338582
Study type Observational
Source Association de Recherche en Cardiologie des Alpes
Contact
Status Active, not recruiting
Phase N/A
Start date November 1, 2015
Completion date April 19, 2018
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04310046 - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial N/A
Active, not recruiting NCT03058627 - Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation N/A
Recruiting NCT05235555 - EffecTAVI Registry
Not yet recruiting NCT05914051 - PRELOAD-TAVI Trial N/A
Active, not recruiting NCT03424941 - The TransCatheter Valve and Vessels Trial N/A
Recruiting NCT06189976 - Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation N/A
Active, not recruiting NCT04298593 - Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study N/A
Completed NCT03966417 - Exercise Training After Transcatheter Aortic Valve Implantation N/A
Completed NCT04286893 - Improved HRV, Inflammation Markers and Endothelial Function After TAVI
Recruiting NCT04831957 - Hypothyroidism After the TAVI Procedure in Elderly Patients N/A
Completed NCT01759563 - Oxygenation of the Cerebrum and Cooling During TAVI - Part I Phase 3
Not yet recruiting NCT05617196 - Virtual PREHAB Study for Patients Undergoing TAVI N/A
Active, not recruiting NCT02700633 - Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI N/A
Not yet recruiting NCT04083040 - Impact of Tilt Angle on Conduction Defects During Transcatheter Aortic Valve Implantation (TAVI) N/A
Recruiting NCT03283501 - Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL) N/A