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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 5 trial groups
Group A: No ECG changes in patients without pre-existing RBBB
Group B: Patients with pre-existing RBBB
Group C: ECG changes in patients with prior conduction disturbances
Group D: New-onset LBBB
Group E: HAVB/CHB during the periprocedural period

Trial outcomes

Primary outcomes

1

Rate of successful algorithm implementation and percentage of patients in each arm of the pre-specified algorithm

Time frame
1 year follow-up
2

Incidence of permanent pacemaker implantation

Time frame
At 30-day follow-up
3

Incidence of permanent pacemaker implantation

Time frame
At 1-year follow-up
4

Incidence of sudden death

Time frame
At 30-day follow-up

Secondary outcomes

1

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

Time frame
Before hospital discharge (between 1 to 30 days)
2

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

Time frame
At 30-day follow-up
3

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

Time frame
At 1 year follow-up
4

Rate and timing of sudden death

Rate and timing of sudden death in each group of the pre-specified algorithm

Time frame
At 30-day follow-up

Other outcomes

Sponsors and contacts

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