Left Bundle-Branch BlockSAVIORNCT07065123
Study on Heart Block Risks Using Outcome-Based Modeling
An observational study of Left Bundle-Branch Block and Aortic Stenosis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Left Bundle-Branch Block, Aortic Stenosis
- What is being tested?
- The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 26 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Study on Atrioventricular and Bundle Branch Block Vulnerability Identified by Outcome-based Risk Modeling （the SAVIOR Study）
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).
Read the detailed description
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).
- Conditions
- Left Bundle-Branch Block, Aortic Stenosis
- Being tested
- The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery
- Keywords
- Transcatheter Aortic Valve Replacement, Permanent Pacemaker Implantation, Left Bundle Branch Block, Predictive Model
- Medical subject headings
- Bundle-Branch Block, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgeryOther
The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery
| Study group | Role | What they receive |
|---|---|---|
| Permanent pacemaker implantation after TAVR surgery | Not described Receives: 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 | Not described Receives: Other: The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Jan 2017
- Primary completion1 Jan 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Bundle-Branch BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingfeng Wang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065123
- Sponsor's protocol ID
- AS-TAVR-2023-04-10
- Acronym
- SAVIOR
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Atrioventricular and Bundle Branch Block Vulnerability Identified by Outcome-based Risk Modeling （the SAVIOR Study）
- ClinicalTrials.gov ID
- NCT07065123
- Acronym / sponsor ID
- SAVIOR / AS-TAVR-2023-04-10
- Conditions
- Left Bundle-Branch Block, Aortic Stenosis
- Keywords
- Transcatheter Aortic Valve Replacement, Permanent Pacemaker Implantation, Left Bundle Branch Block, Predictive Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgeryThe population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery | Other | Complete left bundle branch block occurred after TAVR surgery, Permanent pacemaker implantation after TAVR surgery |
Primary outcome
Permanent Pacemaker Implantation Rate for High-Grade AVB (≥Mobitz II/3°) Post-TAVR (12-Lead ECG Confirmed)
Time frame: 7 years
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
Complete left bundle branch block rate post-TAVR (12-lead ECG confirmed)
Time frame: 7 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Bundle-Branch Block and Aortic Stenosis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Permanent Pacemaker Implantation Rate for High-Grade AVB (≥Mobitz II/3°) Post-TAVR (12-Lead ECG Confirmed) (time frame: 7 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.