An observational study in Left Bundle-Branch Block and Aortic Stenosis, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Completed. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational
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).
In recent years, transcatheter aortic valve replacement (TAVR) has emerged as a minimally invasive surgical approach and has gradually become a standard treatment option for patients with moderate to severe aortic stenosis(AS), particularly those at high surgical risk or deemed ineligible for conventional surgery. TAVR has been widely adopted in clinical practice.
However, post-TAVR cardiac conduction disturbances are among the most frequently observed complications, particularly complete left bundle branch block (CLBBB) and high-degree atrioventricular block (AVB) requiring permanent pacemaker implantation (PPI). These complications are associated with an increased risk of heart failure and cardiac mortality. Identified risk factors include patient-specific characteristics, electrocardiographic features, intraoperative procedural techniques, and the type of device used.
Current research on post-TAVR conduction disorders predominantly focuses on Western populations. However, Chinese AS patients exhibit distinct clinical features-such as higher degrees of valve calcification and a higher prevalence of bicuspid aortic valves-which may lead to differences in risk factors for conduction abnormalities. Moreover, prior studies have largely focused on isolated risk factors rather than developing integrated models to quantify the risk of such complications. Against this backdrop, the purpose of this study is to address the knowledge gap in postoperative risk prediction for Chinese patients. By constructing a risk prediction model tailored to Chinese AS patients for post-TAVR cardiac conduction block, we aim to improve preoperative risk assessment and individualized clinical management, thereby providing actionable guidance for clinical decision-making.
This study included 112 aortic stenosis patients undergoing TAVR at Sun Yat-sen Memorial Hospital (2017-2024), divided into internal (2017-2022) and external (2023-2024) validation cohorts.
Data covered demographics, medical history, ECG, echocardiography, biomarkers, and valve parameters. Outcomes were permanent pacemaker implantation (PPI) ≤48h post-TAVR and complete left bundle branch block (CLBBB).
Univariate logistic regression (p\<0.20 threshold) and stepwise multivariate analysis (R "MASS" package, AIC-based) identified predictors for nomogram development. Model performance was assessed via AUC, C-index, ROC, and Hosmer-Lemeshow test. Internal validation used 1000 bootstrap resamples; external validation employed temporal validation. Analyses were performed in R 4.2.3 (significance: p\<0.05).
94 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.
This study's enrollment of 112 is below the median of 162 across 33 observational studies indexed under Bundle-Branch Block.
Browse Bundle-Branch Block studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: 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
The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery
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
Time frame: 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.
Time frame: 7 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Jan 2025, 96 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University →