A Multimodal Strategy to Screen for and Rule-Out Delayed High-Grade Conduction Disturbances After TAVR

Electrocardiogram (ECG)-based algorithms have been proposed to guide post-TAVI conduction management; however, their ability to predict clinically relevant delayed conduction disturbances remains limited. The research team hypothesized that a rationalized strategy combining ECG findings with simple pre-procedural computed tomography (CT), derived criteria and implantation depth of the device, could improve risk stratification, reduce unnecessary pacemaker implantation (PPI) and preserve patient safety. The investigator conducted a retrospective, multicenter study including 209 consecutive participants who underwent TAVR between February 2023 and September 2024 who were free from permanent pacemaker implantation at discharge. The investigator evaluated the performance of an ECG-based risk stratification algorithm previously described associated with pre-procedural CT parameters, including (membranous septum length, extent of valvular and subvalvular calcifications) and implantation depth. The primary endpoint was the incidence of severe delayed conduction disturbances (including high-grade or complete atrioventricular block, severe or symptomatic bradycardia requiring Permanent Pacemaker Implantation (PPI)) occurring at 3 months in patients according to the presence or absence of risk criteria defined by the algorithm. Secondary endpoints included the algorithm's positive and negative predictive values, assessment of non-syncopal conduction disorders, impact on post-procedural intensive care admission, timing of delayed conduction disturbances, delayed elective pacemaker indications, all-cause and cardiovascular mortality, and cardiac-related rehospitalizations.

NCT Number	NCT07414485
Lead Sponsor	University Hospital, Montpellier
Conditions	Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation, Right Bundle-Branch Block, Left Bundle-Branch Block
Enrollment	209 participants
Start Date	2025-09-23
Primary Completion	2026-04-23 (estimated)
Study Completion	2026-04-23 (estimated)
Updated on ClinicalTrials.gov	2026-05-22