Transcatheter Aortic Valve ImplantationLATETAVINCT07414485
A Multimodal Strategy to Screen for and Rule-Out Delayed High-Grade Conduction Disturbances After TAVR
An observational study of Transcatheter Aortic Valve Implantation and Permanent Pacemaker Implantation, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation, Right Bundle-Branch Block
- What is being tested?
- retrospective health data collection
- How many people
- 209 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2025to 23 Apr 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Any patient aged over 18 years
- underwent TAVI, regardless of the access route and valve type
- discharged from the hospital without a pacemaker
Who cannot join
- Patients with a pre-existing pacemaker prior to TAVI
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- retrospective health data collection
- Keywords
- algorithm to predict delayed high-grade conduction disturbances after transcatheter aortic valve implantation, Right Bundle-Branch Block, Left Bundle-Branch Block, transcatheter aortic valve implantation
- Medical subject headings
- Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective health data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: retrospective health data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From hospital discharge (index TAVI) to 3 months post-procedure between February 2023 and September 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start23 Sep 2025
- Primary completion23 Apr 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ImplantationStudies 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
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414485
- Sponsor's protocol ID
- RECHMPL25_0474
- Acronym
- LATETAVI
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Strategy to Screen for and Rule-Out Delayed High-Grade Conduction Disturbances After TAVR
- ClinicalTrials.gov ID
- NCT07414485
- Acronym / sponsor ID
- LATETAVI / RECHMPL25_0474
- Conditions
- Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation, Right Bundle-Branch Block, Left Bundle-Branch Block
- Keywords
- algorithm to predict delayed high-grade conduction disturbances after transcatheter aortic valve implantation, Right Bundle-Branch Block, Left Bundle-Branch Block, transcatheter aortic valve implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 17 Feb 2026 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants discharged after TAVI without permanent pacemaker | – | Other: retrospective health data collectionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Any patient aged over 18 years
- underwent TAVI, regardless of the access route and valve type
- discharged from the hospital without a pacemaker
Key exclusion criteria (1 listed)
- Patients with a pre-existing pacemaker prior to TAVI
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 |
|---|---|---|
| retrospective health data collectionData 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. | Other | Participants discharged after TAVI without permanent pacemaker |
Primary outcome
The incidence of severe delayed conduction disturbances occurring at 3 months in patients according to the presence or absence of risk criteria
Time frame: From hospital discharge (index TAVI) to 3 months post-procedure between February 2023 and September 2024
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).
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 22 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Implantation and Permanent Pacemaker Implantation, run by University Hospital, Montpellier at 1 site in France.
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 3 inclusion and 1 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The incidence of severe delayed conduction disturbances occurring at 3 months in patients according to the presence or absence of risk criteria (time frame: From hospital discharge (index TAVI) to 3 months post-procedure between February 2023 and September 2024). 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 22 May 2026.