Clinical trial NCT04139616: Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR
Official title: Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following Transcatheter Aortic Valve Replacement. The PROMOTE Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Conduction Disturbances
Transcatheter Aortic Valve Replacement
Permanent Pacemaker Implantation
Keywords: atrioventricular block
complete heart block
high-degree atrioventricular block
intraventricular conduction delay
left bundle branch block
Permanent pacemaker implantation
Right bundle branch block
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with aortic valve disease undergoing transcatheter aortic valve replacement without prior permanent pacemaker

Brief 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.

Detailed description: The objectives of the study are:

* Feasibility: to validate and determine the applicability of a pre-specified algorithm for managing conduction disturbances in consecutive patients undergoing TAVR, also evaluating the percentage of patients included in each group of the algorithm strategy.
* Efficacy: (i) to evaluate the rate of permanent pacemaker implantation in-hospital and at 30 days compared to that of the year prior to the implementation of the protocol, (ii) to determine the incidence of sudden death at 30 days and at 1-year follow-up.

Eligibility criteria: Inclusion Criteria:

-Patients with aortic valve disease undergoing transcatheter aortic valve replacement

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of successful algorithm implementation and percentage of patients in each arm of the pre-specified algorithm
timeFrame: 1 year follow-up
measure: Incidence of permanent pacemaker implantation
timeFrame: At 30-day follow-up
measure: Incidence of permanent pacemaker implantation
timeFrame: At 1-year follow-up
measure: Incidence of sudden death
timeFrame: At 30-day follow-up
measure: Incidence of sudden death
timeFrame: At 1-year follow-up
Secondary outcomes:
measure: Rate, timing of and reasons for permanent pacemaker implantation
timeFrame: Before hospital discharge (between 1 to 30 days)
measure: Rate, timing of and reasons for permanent pacemaker implantation
timeFrame: At 30-day follow-up
measure: Rate, timing of and reasons for permanent pacemaker implantation
timeFrame: At 1 year follow-up
measure: Rate and timing of sudden death
timeFrame: At 30-day follow-up
measure: Rate and timing of sudden death
timeFrame: At 1-year follow-up
measure: Evaluation of arrhythmic events in patients with continuous ECG monitoring
timeFrame: After hospital discharge (up to 1-year)
measure: Evaluation of the rate and timing of permanent pacemaker implantation
timeFrame: After hospital discharge (up to 1-year)
measure: Rate of PPI among valve types
timeFrame: At 30-day follow-up
measure: Rate of PPI among valve types
timeFrame: At 1-year follow-up
measure: Pace dependency and pacing rate
timeFrame: At 30-day follow-up
measure: Pace dependency and pacing rate
timeFrame: At 1-year follow-up
measure: Factors associated with sudden death or permanent pacemaker implantation
timeFrame: At 30-day follow-up
measure: Factors associated with sudden death or permanent pacemaker implantation
timeFrame: At 1-year follow-up
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: IUCPQ
Study officials:
References:
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