Study on Heart Block Risks Using Outcome-Based Modeling

NCT07065123 | Completed

• 1 other identifier: AS-TAVR-2023-04-10
• Study Type: observational
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study developed a prediction model for high-grade atrioventricular block (AVB) and complete left bundle branch block (CLBBB) following transcatheter aortic valve replacement (TAVR) in Chinese patients with aortic stenosis (AS). Analyzing 112 patients from Sun Yat-sen Memorial Hospital (2017-2024), the study incorporated clinical, electrocardiographic, and procedural variables to identify risk factors via logistic regression. A nomogram was constructed and validated internally (bootstrapping) and externally (temporal validation), with performance assessed using AUC, C-index, and calibration tests. The model aims to improve preoperative risk stratification and guide individualized management for TAVR-related conduction disturbances in this understudied population. Analyses were conducted in R 4.2.3 (significance: \*p\* \< 0.05).

Conditions

Left Bundle-Branch Block; Aortic Stenosis

Keywords

Transcatheter Aortic Valve Replacement; Permanent Pacemaker Implantation; Left Bundle Branch Block; Predictive Model

Outcome Measures

Primary Outcomes (2)

• Permanent Pacemaker Implantation Rate for High-Grade AVB (≥Mobitz II/3°) Post-TAVR (12-Lead ECG Confirmed)

  Number of participants requiring permanent pacemaker implantation (PPI) due to high-grade atrioventricular block (AVB; ≥2nd degree Mobitz II or 3rd degree) within 48 hours post-TAVR, as clinically indicated and confirmed by 12-lead ECG and cardiology consultation

  7 years

• Complete left bundle branch block rate post-TAVR (12-lead ECG confirmed)

  Number of participants developing new complete left bundle branch block , as defined by standard ECG criteria (QRS duration ≥120ms with characteristic morphology), within 48 hours post-transcatheter aortic valve replacement.

  7 years

Study Arms (2)

Permanent pacemaker implantation after TAVR surgery

Other: The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery

Complete left bundle branch block occurred after TAVR surgery

Other: The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery

Interventions

The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery OTHER

The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery

Complete left bundle branch block occurred after TAVR surgery; Permanent pacemaker implantation after TAVR surgery

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This single-center retrospective study enrolled 112 consecutive patients with aortic stenosis (AS) who underwent TAVR at the Department of Cardiology, Sun Yat-sen Memorial Hospital between January 2017 and December 2024. The cohort was divided into: Internal validation cohort: Patients treated from 2017 to 2022 (n=68) External validation cohort: Patients treated from 2023 to 2024 (n=44)

You may qualify if:

• Adult patients (≥18 years old) with severe symptomatic aortic stenosis (AS) meeting 2021 ESC/EACTS Guidelines and Chinese Expert Consensus criteria (AVA \<1.0 cm², or peak jet velocity ≥4.0 m/s, or mean gradient ≥40 mmHg)
• Scheduled to undergo transcatheter aortic valve replacement (TAVR) in Sun Yat-Sen Memorial Hospital

You may not qualify if:

• Pre-existing complete left bundle branch block (CLBBB) on baseline ECG
• Patients with pre-existing permanent pacemaker implantation
• Inability to comply with follow-up protocol

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Bundle-Branch Block; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 15, 2025
• Study Start: January 1, 2017
• Primary Completion: January 1, 2025
• Study Completion: June 26, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share