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

Recruiting

• Conditions: Conduction Disturbances; Transcatheter Aortic Valve Replacement; Permanent Pacemaker Implantation

• Registration Number: NCT04139616
• Lead Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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.

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Study Start: 2020-02-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2024-12-25
• Study Completion: 2025-02-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 1-year follow-up
Incidence of sudden death	At 1-year follow-up

Secondary Outcome Measures

Name	Time	Method
Rate and timing of sudden death	At 1-year follow-up	Rate and timing of sudden death in each group of the pre-specified algorithm
Factors associated with sudden death or permanent pacemaker implantation	At 1-year follow-up	Determine factors associated with sudden death or permanent pacemaker implantation during the follow-up period overall and in each algorithm group
Evaluation of the rate and timing of permanent pacemaker implantation	After hospital discharge (up to 1-year)
Evaluation of arrhythmic events in patients with continuous ECG monitoring	After hospital discharge (up to 1-year)	Evaluation of arrhythmic events in patients with continuous ECG monitoring at hospital discharge
Rate of PPI among valve types	At 1-year follow-up	Compare rate of permanent pacemaker implantation among different valve types
Pace dependency and pacing rate	At 1-year follow-up	Determine the pace dependency and pacing rate in patients with periprocedural permanent pacemaker implantation (overall and in each subgroup of the algorithm)
Rate, timing of and reasons for permanent pacemaker implantation	At 1 year follow-up	Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm

Trial Locations

Locations (1)

IUCPQ; 🇨🇦 Quebec, Canada