About this trial
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients. Despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of a large proportion of such patients. The implementation of a pre-specified treatment strategy translating into a more uniform practice regarding the management of conduction disturbances post-TAVR applied to a large cohort of patients would permit to identify the benefits and drawbacks of each specific aspect of the treatment algorithm proposal. This may also help to improve both the management and clinical outcomes of the complex group of patients with conduction disturbances associated with TAVR. In the end, the final objective of a pre-specified strategy for managing conduction disturbances post-TAVR should be to obtain a low rate of PPM without increasing the risk of sudden death or life threatening arrhythmic events following hospital discharge, and all this while avoiding an excessive prolongation of the hospitalization period following the TAVR procedure.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Prior permanent pacemaker
Failure to provide signed informed consent for data collection
Impossibility for a follow-up
Unwillingness to follow the pre-specified strategy for the management of conduction disturbances
Trial population
Patients with aortic valve disease undergoing transcatheter aortic valve replacement without prior permanent pacemaker
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Rate of successful algorithm implementation and percentage of patients in each arm of the pre-specified algorithm
Incidence of permanent pacemaker implantation
Incidence of permanent pacemaker implantation
Incidence of sudden death
Secondary outcomes
Rate, timing of and reasons for permanent pacemaker implantation
Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm
Rate, timing of and reasons for permanent pacemaker implantation
Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm
Rate, timing of and reasons for permanent pacemaker implantation
Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm
Rate and timing of sudden death
Rate and timing of sudden death in each group of the pre-specified algorithm
Sponsors and contacts
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