NCT07414485

Evaluation and Validation of an Algorithm for Predicting Delayed Conduction Disorders After TAVR: a Multicentre Observational Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 210 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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. We 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. We conducted a retrospective, multicenter study including 210 consecutive patients who underwent TAVR between February 2023 and September 2024 who were free from permanent pacemaker implantation at discharge. We 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.

Conditions

• Delayed High-grade Conduction Disturbances After Transcatheter Aortic Valve Implantation

Interventions

Type	Name	Description
OTHER	retrospective health data collection	Data collected from the medical records of patients followed in the participating centers Pre- and post-TAVI conduction disturbances that did not warrant in-hospital permanent pacemaker implantation, including: age, sex, key care dates (procedure, discharge, follow-up visits). Cardiac CT anatomy: membranous septum length; location/extent of valvular and LVOT calcifications Procedural details: annular perimeter/area; device implantation depth; device oversizing vs annulus. Clinical course \& outcomes: non-syncopal conduction disturbances; ICU stay (need and impact); timing of delayed conduction disturbances; delayed/elective PPI indications (e.g., persistent left bundle branch block (LBBB) with heart failure); mortality (all-cause and cardiovascular); cardiac rehospitalizations; survival status at follow-up. 12-lead ECGs, cardiac CT, medical reports, medical history.

Timeline

• Start date: 2025-09-23
• Primary completion: 2026-09-23
• Completion: 2026-09-23
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: France