Transcatheter Aortic Valve Replacement Clinical Trial
Official title:
HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients
TAVI induced LBBB is a complication that occurs between 7 and 65 % of the cases, numbers
that differ considerably between devices. There is an increased risk of progression to total
AV‐block at follow‐up, with the risk of brady‐arrhythmic death.
The aim of the study is to elucidate the anatomical location of the conduction pathology of
a TAVI induced LBBB. This could impact valve design and placement and thereby reduce the
number of new LBBB induced by TAVI in the future. Furthermore, finding predictors for
progression to a high degree AV block in the follow‐up (and thus an indication for permanent
pacemaker) could improve management of post‐operative conduction abnormalities and prevent
the risk of brady‐arrhythmic death.
A prospective, single center, non‐randomized pilot study in which patients will undergo an
electrophysiology (EP) study during the TAVI procedure.
All patients eligible for inclusion will undergo an electrophysiology (EP) study during the
TAVI procedure. For the purpose of EP measurements, a His‐catheter will be placed at the
beginning of the procedure and remain in the same location until the end of the procedure.
Continuous HV measurements will be collected, together with a continuous surface ECG, during
the entire TAVI procedure. The different steps in TAVI procedure will be registered.
During the study, patients will undergo regular electrocardiographic examinations at the
outpatient clinic (before implantation, after implantation, before discharge and after 6
weeks, 6 and 12 months post‐implantation). These are part of the standard healthcare after
the TAVI procedure.
The research protocol has been approved by the ethical committee (METC).
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