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

NCT07414485 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 209

Last updated 2026-05-22

No results posted yet for this study

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. 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.

Conditions

  • Transcatheter Aortic Valve Implantation
  • Permanent Pacemaker Implantation
  • Right Bundle-Branch Block
  • Left Bundle-Branch Block

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-23
Primary Completion
2026-04-23
Completion
2026-04-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07414485 on ClinicalTrials.gov