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

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.

Study Overview

• Status: Completed
• Conditions: Left Bundle-Branch Block; Transcatheter Aortic Valve Implantation; Right Bundle-Branch Block; Permanent Pacemaker Implantation
• Intervention / Treatment: Other: retrospective health data collection

• Study Type: Observational
• Enrollment (Actual): 209

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34090
    • Faculté de médecine montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Any patient aged over 18 years
• underwent TAVI, regardless of the access route and valve type
• discharged from the hospital without a pacemaker

Exclusion Criteria:

• Patients with a pre-existing pacemaker prior to TAVI

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Participants discharged after TAVI without permanent pacemaker; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From hospital discharge (index TAVI) to 3 months post-procedure between February 2023 and September 2024

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2025
• Primary Completion (Actual): April 23, 2026
• Study Completion (Actual): April 23, 2026

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: transcatheter aortic valve implantation; Right Bundle-Branch Block; Left Bundle-Branch Block; algorithm to predict delayed high-grade conduction disturbances after transcatheter aortic valve implantation
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Block; Pathological Conditions, Signs and Symptoms; Bundle-Branch Block
• Other Study ID Numbers: RECHMPL25_0474

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No