Post-TAVI Clinical Trial
Official title:
Assessment of the Prognosis of Persistent Left Bundle Branch Block (LBBB) After Transcatheter Aortic Valve Implantation (TAVI ) by an Electrophysiological and Remote Monitoring Risk-adapted Algorithm
The replacement of the aortic valve by percutaneous approach (called TAVI) is a therapy
which is booming in the management of aortic stenosis. It concerns patients who have a high
surgical risk presenting comorbidity, for whom a classic approach by surgery of valvular
replacement seems unreasonable. Beyond its feasibility, the implantation of a TAVI is less
invasive and improves the patient's morbi-mortality. The appearance of a Left Bundle Branch
Block (LBBB) is one of the most frequent complications of this procedure and represents an
important risk of atrio-ventricular (AV) high grade conductive disorders requiring permanent
pacing in 5 in 15 % of the cases in 1 year.
De novo LBBB is associated with a more important morbi-mortality in post-TAVI situation.
However, there are no predictive elements of these conductive disorders. Besides, the
incidence and the deadline of appearance of this AV disorders are not established. It seems
relevant to propose a new stratification based on ECG and endocavitary data. The monitoring
of the conductive disorders is allowed by remote monitoring thanks to the implantation of a
pacemaker or an implantable holter allowing to determine the incidence and the deadline of
appearance of high grade AV conduction disorders.
The aim of this protocol is to study the appearance of the high grade AV conductive
disorders at 12 months by monitoring for patients with a de novo LBBB after TAVI from an
adapated algorithm to the risk and based on an early electrophysiological evaluation.
The recruitment of patients takes place in each cardiology department. The project is
submitted to the Ethics Committee .
The patients are informed about this study by the investigator. After a reflection period
and an answer to the possible questions, the patient is included. The informed consent is
signed.
Every patient included with a de novo LBBB, persistent that is observed beyond 24 hours
after the TAVI procedure, will benefit from an endocavitary electrophysiological exploration
. According to the meditative delay of conduction, a pacemaker will be implanted in case of
delay lengthened HV (> 70 ms) or of infrahissian block, in the opposite case the
implantation of an holter with remote monitoring will be made.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label