TAVI(Transcatheter Aortic Valve Implantation)LBB(AP)TAVINCT07909239
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
A study testing Left bundle branch area pacing with pacemaker and Implantation loop recorder in people with TAVI(Transcatheter Aortic Valve Implantation) and Left Bundle Branch Block, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Patients with new-onset complete LBBB (QRS > 120 ms, persisting > 24 h after TAVI) and moderately reduced LVEF (35-50%) will be screened in participating centers. Eligible patients will be centrally randomized 1:1 (stratified by center and atrial fibrillation (yes/no)) to either: Experimental arm: Left bundle branch… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block, Reduced Left Ventricular Ejection Fraction
- What is being tested?
- Left bundle branch area pacing with pacemaker and Implantation loop recorder
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2026to 15 Oct 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with new-onset complete left bundle branch block (LBBB) defined as QRS duration >120 ms, occurring after TAVI and persisting for >24 hours on ECG. New-onset complete LBBB will be confirmed by QRS duration >120 ms together with standard morphological criteria (broad, notched or slurred R waves in leads I, aVL, V5 and V6, with absence of Q waves in V5-V6), assessed by the site cardiologist and confirmed by the adjudication committee, in line with current ESC and ACC/AHA/HRS recommendations.
- Left ventricular ejection fraction (LVEF) between 35% and 50%, assessed within one month before TAVI, in a stable hemodynamic state.
- Patients implanted with a self-expanding or balloon-expandable valve.
- Age ≥ 18 years.
- TAVI procedure performed according to current ESC guidelines. The applicable reference is the 2025 ESC/EACTS Guidelines for the management of valvular heart disease (Praz, et al. Eur Heart J. (2025) 46, 4635-4736), or any subsequent official ESC update in force at the time of each patient's procedure.
- Life expectancy > 1 year.
- Affiliation to a social security scheme
- Written informed consent provided before study enrollment.
Who cannot join
- Permanent pacemaker implantation (PPI) before TAVI.
- Complete atrioventricular block after TAVI leading to immediate PPI.
- Permanent pacemaker implantation after TAVI for another indication (non-protocol).
- Pre-existing LBBB before TAVI.
- Trans-venous permanent pacemaker implantation: No superior vena cava access or mechanical tricuspid valve.
- Pregnancy or breastfeeding.
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- No affiliation to a social security scheme.
- Refusal to participate or withdrawal of informed consent.
- Incapacity to consent.
- Adults under legal protection (trusteeship, guardianship, curatorship).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Chu Clermont Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Romain ESCHALIER
About this study
Official title: Comparison of Left Bundle Branch Area Pacing (LBB(AP)) and Implantable Loop Recorder (ILR) in Patients With New-onset Left Bundle Branch Block and Moderately Reduced LVEF After Transcatheter Aortic Valve Implantation (TAVI): A Randomized Multicenter Study.
Patients with new-onset complete LBBB (QRS > 120 ms, persisting > 24 h after TAVI) and moderately reduced LVEF (35-50%) will be screened in participating centers.
Eligible patients will be centrally randomized 1:1 (stratified by center and atrial fibrillation (yes/no)) to either:
Read more
- Experimental arm: Left bundle branch area pacing (LBB(AP)) with Biotronik pacemaker and dedicated conduction system pacing leads.
- Control arm: Implantable loop recorder (ILR, Biotronik BIOMONITOR IV) for rhythm monitoring.
The occurrence of the following events within 12 months of randomization will be evaluated: hospitalization for heart failure, syncope or hemodynamically significant dizziness, or high-grade atrioventricular conduction disturbance.
The impact of LBB(AP) compared to ILR monitoring will be evaluated at 6, 12, 24, and 36 months regarding: incidence of atrial fibrillation; incidence of non-sustained ventricular tachycardia; evolution of left ventricular ejection fraction; quality of life; hospitalizations; mortality; medico-economic outcomes; qccurrence of high-grade AV conduction disorders beyond 12 months; omplications related to pacemaker or ILR implantation; unscheduled pacemaker implantation in the ILR group.
Patients will be monitored following a regular schedule that includes clinical visits, transthoracic echocardiography , ECG, remote device monitoring, and EQ-5D at 6, 12, 24 and 36 months.
- Conditions
- TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block, Reduced Left Ventricular Ejection Fraction
- Being tested
- Left bundle branch area pacing with pacemaker, Implantation loop recorder
- Keywords
- TAVI, new onset left bundle branch block, implantable loop recorder, left bundle branch area pacing, moderately reduced LVEF (35-50%)
- 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.
Left bundle branch area pacing with pacemakerProcedure or surgery
LBB(AP) procedure will be performed by experienced operators according international guidelines and expert consensus. The implantation technique will be those used routinely in these expert centers.
The procedure will begin with a vein access (axillary, sub-clavian or cephalic). The atrial, if necessary, will be implanted as usual practice. LBB(AP) lead will be implanted as recommended. LBB(AP) positioning criteria, as described in reference clinical studies, will be checked in order to differentiate between LBB(AP) and deep septal pacing.
Implantation loop recorderProcedure or surgery
ILR Procedure will be performed by experienced operators according international guidelines and expert consensus. The implantation technique will be those used routinely in these expert centers.
The implanted device will be a Biomonitor IV (Biotronik, Berlin, Germany) and next generation if necessary.
The implantable Loop Recorder is a single-lead ECG monitor of small size with long-term functionality (approximately 3 to 5 years). It is implanted under local anesthesia in the subcutaneous space of the left thoracic region (incision at the level of the 4th left intercostal space at a 45° angle).
| Study group | Role | What they receive |
|---|---|---|
| Left bundle branch area pacing with pacemaker and conduction system pacing (AMVIA SKY DR-T device) | Experimental | Not described Receives: Procedure: Left bundle branch area pacing with pacemaker |
| Implantable loop recorder for rhythm monitoring (ILR, Biotronik BIOMONITOR IV Device) | Other | Control arm Receives: Procedure: Implantation loop recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first occurrence of one of the following events : hospitalization for worsening heart failure, episode of syncope or dizziness, high-grade atrioventricular conduction disturbance)
The primary efficacy endpoint is a composite clinical outcome evaluated at 12 months after randomization, defined as the first occurrence of one of the following events:
- Hospitalization for worsening heart failure,
- Episode of syncope or dizziness,
- High-grade atrioventricular conduction disturbance (second-degree AV block type II or third-degree AV block requiring implantation of a permanent pacemaker, documented > 3 seconds on ILR or ECG)).
The composite endpoint will be analyzed as time-to-event data with death considered as a competing risk.
Measured: From randomization to 12 follow up
Secondary outcomes (8)
Incidence of atrial fibrillation, ventricular tachycardia, non-sustained ventricular tachycardia
Measured: At 6,12, 24 and 36 months after randomization
Evolution of LVEF
Measurement of LVEF at inclusion and at each follow-up time point. The change in LVEF over time will be assessed relative to the date of inclusion and the preceding time point.
Measured: At 6,12, 24 and 36 months after randomization
Evolution of Quality of life (EQ-5D)
Measurement of EQ-5D at inclusion and at each follow-up time point. The change in EQ-5D over time will be assessed relative to the date of inclusion and the preceding time point.
Measured: At 6, 12, 24 and 36 months after randomization
Incidence of Hospitalizations (all-cause, cardiovascular, HF-related)
Measured: At 6, 12, 24 and 36 months after randomization
Incidence of Mortality (all-cause, cardiovascular, HF-related)
Measurement of the cumulative incidence of all-cause, cardiovascular, and heart failure-related mortality at 6, 12, 24, and 36 months after randomization, based on the occurrence and documented cause of death.
Measured: At 6, 12, 24 and 36 months after randomization
Medico-economic evaluation
Measured: At 6, 12, 24 and 36 months after randomization
Complications related to pacemaker or ILR implantation
Measured: At 6, 12, 24 and 36 months after randomization
Unscheduled pacemaker implantation in the ILR group
Measured: At 6, 12, 24 and 36 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Oct 2033 (estimated)
- Study completion15 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TAVI(Transcatheter Aortic Valve Implantation)Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909239
- Sponsor's protocol ID
- RBHP 2025 ESCHALIER 2
- Acronym
- LBB(AP)TAVI
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Left Bundle Branch Area Pacing (LBB(AP)) and Implantable Loop Recorder (ILR) in Patients With New-onset Left Bundle Branch Block and Moderately Reduced LVEF After Transcatheter Aortic Valve Implantation (TAVI): A Randomized Multicenter Study.
- ClinicalTrials.gov ID
- NCT07909239
- Acronym / sponsor ID
- LBB(AP)TAVI / RBHP 2025 ESCHALIER 2
- Conditions
- TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block, Reduced Left Ventricular Ejection Fraction
- Keywords
- TAVI, new onset left bundle branch block, implantable loop recorder, left bundle branch area pacing, moderately reduced LVEF (35-50%)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Oct 2033 (estimated)
- Study completion
- 15 Oct 2034 (estimated)
- First posted
- 2 Nov 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.
Patients with new-onset complete LBBB (QRS > 120 ms, persisting > 24 h after TAVI) and moderately reduced LVEF (35-50%) will be screened in participating centers.
Eligible patients will be centrally randomized 1:1 (stratified by center and atrial fibrillation (yes/no)) to either:
- Experimental arm: Left bundle branch area pacing (LBB(AP)) with Biotronik pacemaker and dedicated conduction system pacing leads.
- Control arm: Implantable loop recorder (ILR, Biotronik BIOMONITOR IV) for rhythm monitoring.
The occurrence of the following events within 12 months of randomization will be evaluated: hospitalization for heart failure, syncope or hemodynamically significant dizziness, or high-grade atrioventricular conduction disturbance.
The impact of LBB(AP) compared to ILR monitoring will be evaluated at 6, 12, 24, and 36 months regarding: incidence of atrial fibrillation; incidence of non-sustained ventricular tachycardia; evolution of left ventricular ejection fraction; quality of life; hospitalizations; mortality; medico-economic outcomes; qccurrence of high-grade AV conduction disorders beyond 12 months; omplications related to pacemaker or ILR implantation; unscheduled pacemaker implantation in the ILR group.
Patients will be monitored following a regular schedule that includes clinical visits, transthoracic echocardiography , ECG, remote device monitoring, and EQ-5D at 6, 12, 24 and 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left bundle branch area pacing with pacemaker and conduction system pacing (AMVIA SKY DR-T device) | Experimental | Procedure: Left bundle branch area pacing with pacemaker |
| Implantable loop recorder for rhythm monitoring (ILR, Biotronik BIOMONITOR IV Device) | Other | Procedure: Implantation loop recorderControl arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with new-onset complete left bundle branch block (LBBB) defined as QRS duration >120 ms, occurring after TAVI and persisting for >24 hours on ECG. New-onset complete LBBB will be confirmed by QRS duration >120 ms together with standard morphological criteria (broad, notched or slurred R waves in leads I, aVL, V5 and V6, with absence of Q waves in V5-V6), assessed by the site cardiologist and confirmed by the adjudication committee, in line with current ESC and ACC/AHA/HRS recommendations.
- Left ventricular ejection fraction (LVEF) between 35% and 50%, assessed within one month before TAVI, in a stable hemodynamic state.
- Patients implanted with a self-expanding or balloon-expandable valve.
- Age ≥ 18 years.
- TAVI procedure performed according to current ESC guidelines. The applicable reference is the 2025 ESC/EACTS Guidelines for the management of valvular heart disease (Praz, et al. Eur Heart J. (2025) 46, 4635-4736), or any subsequent official ESC update in force at the time of each patient's procedure.
Key exclusion criteria (10 listed)
- Permanent pacemaker implantation (PPI) before TAVI.
- Complete atrioventricular block after TAVI leading to immediate PPI.
- Permanent pacemaker implantation after TAVI for another indication (non-protocol).
- Pre-existing LBBB before TAVI.
- Trans-venous permanent pacemaker implantation: No superior vena cava access or mechanical tricuspid valve.
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 |
|---|---|---|
| Left bundle branch area pacing with pacemakerLBB(AP) procedure will be performed by experienced operators according international guidelines and expert consensus. The implantation technique will be those used routinely in these expert centers. The procedure will begin with a vein access (axillary, sub-clavian or cephalic). The atrial, if necessary, will be implanted as usual practice. LBB(AP) lead will be implanted as recommended. LBB(AP) positioning criteria, as described in reference clinical studies, will be checked in order to differentiate between LBB(AP) and deep septal pacing. | Procedure or surgery | Left bundle branch area pacing with pacemaker and conduction system pacing (AMVIA SKY DR-T device) |
| Implantation loop recorderILR Procedure will be performed by experienced operators according international guidelines and expert consensus. The implantation technique will be those used routinely in these expert centers. The implanted device will be a Biomonitor IV (Biotronik, Berlin, Germany) and next generation if necessary. The implantable Loop Recorder is a single-lead ECG monitor of small size with long-term functionality (approximately 3 to 5 years). It is implanted under local anesthesia in the subcutaneous space of the left thoracic region (incision at the level of the 4th left intercostal space at a 45° angle). | Procedure or surgery | Implantable loop recorder for rhythm monitoring (ILR, Biotronik BIOMONITOR IV Device) |
Primary outcome
The first occurrence of one of the following events : hospitalization for worsening heart failure, episode of syncope or dizziness, high-grade atrioventricular conduction disturbance)
Time frame: From randomization to 12 follow up
The primary efficacy endpoint is a composite clinical outcome evaluated at 12 months after randomization, defined as the first occurrence of one of the following events: 1. Hospitalization for worsening heart failure, 2. Episode of syncope or dizziness, 3. High-grade atrioventricular conduction disturbance (second-degree AV block type II or third-degree AV block requiring implantation of a permanent pacemaker, documented > 3 seconds on ILR or ECG)). The composite endpoint will be analyzed as time-to-event data with death considered as a competing risk.
8 secondary outcomes
Incidence of atrial fibrillation, ventricular tachycardia, non-sustained ventricular tachycardia
Time frame: At 6,12, 24 and 36 months after randomization
Evolution of LVEF
Time frame: At 6,12, 24 and 36 months after randomization
Evolution of Quality of life (EQ-5D)
Time frame: At 6, 12, 24 and 36 months after randomization
Incidence of Hospitalizations (all-cause, cardiovascular, HF-related)
Time frame: At 6, 12, 24 and 36 months after randomization
Incidence of Mortality (all-cause, cardiovascular, HF-related)
Time frame: At 6, 12, 24 and 36 months after randomization
Medico-economic evaluation
Time frame: At 6, 12, 24 and 36 months after randomization
Complications related to pacemaker or ILR implantation
Time frame: At 6, 12, 24 and 36 months after randomization
Unscheduled pacemaker implantation in the ILR group
Time frame: At 6, 12, 24 and 36 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes
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Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
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Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left bundle branch area pacing with pacemaker and Implantation loop recorder in people with TAVI(Transcatheter Aortic Valve Implantation) and Left Bundle Branch Block, run by University Hospital, Clermont-Ferrand 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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 2 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first occurrence of one of the following events : hospitalization for worsening heart failure, episode of syncope or dizziness, high-grade atrioventricular conduction disturbance) (time frame: From randomization to 12 follow up). 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 2 Nov 2026.