An observational study in Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation and Right Bundle-Branch Block, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by University Hospital, Montpellier · Observational
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.
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This study's enrollment of 209 is above the median of 162 across 33 observational studies indexed under Bundle-Branch Block.
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The study population consisted of 209 consecutive patients underwent TAVR using contemporary transcatheter valve prostheses and were managed according to a standardized ECG-based post-procedural conduction monitoring algorithm.
Only patients without pre-existing permanent pacemaker implantation and without immediate post-procedural indication for permanent pacing were included in the analysis. This population represents a clinically relevant group in whom post-discharge conduction risk stratification is particularly challenging and in whom optimization of monitoring strategies is most impactful.
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Exclusion Criteria:
Participants discharged after TAVI without permanent pacemaker, not meeting any algorithm-defined risk criteria. ECG at baseline/post-procedure shows no qualifying conduction abnormality, and pre-procedural CT shows no high-risk anatomic features (e.g., membranous septum ≥ 6 mm and no high-risk valvular/LVOT ( left ventricular outflow tract) calcifications). Procedural characteristics (e.g., implantation depth) are not in the high-risk range. Follow-up according to standard of care at \~1 and \~3 months.
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.
The incidence of severe delayed conduction disturbances occurring at 3 months in patients according to the presence or absence of risk criteria
Percentage of participants discharged without a permanent pacemaker who develop a severe delayed conduction disturbance within 3 months, defined as high-grade AV (atrioventricular) block or severe/symptomatic bradyarrhythmia (e.g., sinus node dysfunction or atrial fibrillation (AF) with ventricular rate \<40 bpm) requiring therapeutic intervention (medication change, unplanned hospitalization, temporary or permanent pacemaker). Events are ascertained from ECGs/clinical assessments/records at routine \~1- and \~3-month follow-up and reported overall and stratified by the protocol-defined risk algorithm (ECG, cardiac CT anatomy-including membranous septum length and valvular/LVOT calcifications-and implantation depth).
Time frame: From hospital discharge (index TAVI) to 3 months post-procedure between February 2023 and September 2024
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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