Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR

Condition(s) studied

Study summary

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

Primary outcome measure(s)

• Rate of successful algorithm implementation and percentage of patients in each arm of the pre-specified algorithm — 1 year follow-up
• Incidence of permanent pacemaker implantation — At 30-day follow-up
• Incidence of permanent pacemaker implantation — At 1-year follow-up
• Incidence of sudden death — At 30-day follow-up
• Incidence of sudden death — At 1-year follow-up

Trial sites (1)

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